Role of Walking and khadiradi tablet in diabetes
- Conditions
- Type 2 diabetes mellitus without complications,
- Registration Number
- CTRI/2019/06/019580
- Lead Sponsor
- Director IPGT and RA GAU Jamnagar
- Brief Summary
**AIMS:**
To evaluate the clinical efficacy of *Khadiradi Ghanati* and *Chankraman* in *Madhumeha* (Type 2 Diabetes).
**OBJECTIVES:**
To prove and compare the efficacy of *Khadiradi Ghanvati* and *Chankraman*in the management of *Madhumeha (*DiabetesType 2).
**PLAN OF STUDY:**
The study work will be divided into following parts
1. Conceptual study
2. Pharmacognostical
3. Pharmaceutical study
4. Clinical study
**1. Conceptual study**:
Various ayurvedictextbooks and previous research works related with the subject will be thoroughly screened, analyzed, summarized and referred for *Madhumeha* and diabetes and of the drugs under trial.
2. **Pharmacognostical study**:
Detailed pharmacognostical study will be done in the Pharmacognosy lab of IPGT & RA, Jamnagar where all the drugs of *khadiradi ghanvati* will be authenticated by appropriate methods.
**3.Pharmaceutical study**:
Pharmaceutical study of the finished product will be done in the Pharmaceutical Chemistry lab of I.P.G.T.& R.A, G.A.U, Jamnagar.
3. **Clinical Study:**
For the clinical trial approximately 40Patients complaining of *,Pipasa (*Polydipsia*),Kara-Pada Daha Supti, Nidradhikya, Alasya*, *Swed-aanga gandha, Asyamadhurya, Malam kaye*, *Netra-jihva-shravana-updeh*, *Vishra sharirgandha*, *Shithila Angata*, *Shita Priyatwam*, *Shwasa*, *Snigdha gatrata*, *Picchhila Patrata*, *Dantadinaam Maladhytwa, Gurugatrata*, Nocturia, Polyphagia *e*tc. fulfilling the criteria of inclusion and giving their consent to participate in the clinical trial will be selected irrespective of their sex, religion, occupation caste etc. from OPD and IPD of *Kayachikitsa* department of I.P.G.T. & R.A Hospital, Gujarat Ayurved University, Jamnagar. Patients on Oral Hypoglycemic Agents and anti- hypertensive drugs will be allowed to continue their conventional treatment.
**DRUG REVIEW:**
**Table no 1 Ingredients of *Khadiradi Ghanvati*:**
| | | | |
| --- | --- | --- | --- |
|**Drug Name**
**Botanical Name**
**Part**
**Part Used**
|*Khadir*
Acacia Catechu Wild
1 part
Stembark*,* Heartwood
|*Kadar*
Acacia Suma Kurg.
1 part
Stembark*,* Heartwood
|*Puga*
Areca Catechu Linn.
1 part
Fruit
**Table no. 2 *Rasapanchaka*****of Ingredients of *Khadiradi Ghanvati*:**
| | | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
|***Drug***
***Rasa***
***Guna***
***Virya***
***Vipaka***
***Doshakarma***
***Prabhava***
|*Khadir*
*Tikta*
*Kasaya*
*Laghu*
*Ruksha*
*Shita*
*Katu*
*Kapha-Pitta*
*Shamaka*
*Medohar, Pramehhar, Kushthagna*
|*Kadar*
*Tikta*
*Kashaya*
*Laghu*
*Ruksha*
*Shita*
*Katu*
*Khapha-Pitta*
*Shamaka*
*Medohar, Pramehhar, Kushthagna*
|*Puga*
*Kashaya, Madhur*
*Guru*
*Ruksha*
*Shita*
*Katu*
*Khaph-Pitta*
*Shamaka*
*Deepana, Mohanam, Krimighan*
**METHODS OF PREPARATION:**
*Khadiradi Ghanvati* will be prepared under guidance of Pharmacy of I.P.G.T & R.A as per classical text reference.
**STUDY DESIGN:**
Study type: Interventional
Intervention Model: Two Groups Assignment
Allocation: Randomized
Purpose: Treatment
Masking: Open
Timing: Prospective
End point: Efficacy and safety
Total 40 patients will be enrolled in study. The patients fulfilling inclusion criteria from OPD and IPD of IPGT & RA, Hospital, Jamnagar will be divided into two group on the basis of computer generated randomization method.
**DIAGNOSTIC CRITERIA:**
**1.**Presence of few features of *Madhumeha* like *Avila Mutrata*, *Prabhut Mutrata(*Polyuria*), Kesheshu, jatilibhava, Keshnaka ativriddh, Pipilika abhisaranam* etc.
2. According to WHO (2006) recommendations for the diagnostic criteria for diabetes Fasting Blood Plasma glucose ≥7.0mmol/l (126mg/dl) OR Post Prandial Blood Plasma glucose ≥11.1mmol/l (200mg/dl).
**INCLUSION CRITERIA:**
1. Patients of both male and female sexes from age group 20-60 years.
2. Signs and symptoms of *Madhumeha.*
*3.*Fasting Blood Plasma glucose. ≥7.0mmol/l (126mg/dl) OR Post Prandial Blood Plasma Glucose ≥11.1mmol/l (200mg/dl).
4. BMI ≥ 23 Kg/m2to 30 Kg/m2
5. Diagnosed cases who are not practicing 6 km regular walk.
**EXCLUSION CRITERIA:**
1. Patients of Diabetes mellitus receiving Insulin.
2. Patients having chronic complications of Diabetes mellitus.
3. MIcro vascular Retinopathy, Neuropathy and Nephropathy.
4. Macro vascular Coronary artery disease, Peripheral vascular disease & Cerebro-vascular disease.
5. Other chronic debilitating disease like STD etc.
6. Pregnant and lactating women.
7. Tuberculosis and HIV.
8. Patients with *Prameha Pidika* (carbuncle, furuncles, abscess)
**INVESTIGATIONS:**
Investigations will be carried out in both groups, before treatment and after completion of treatment for the purpose of assessing the effect of therapy, general condition of the patients and to exclude other pathology.
**1.** Routine haematological investigations like Hb%, ESRmm/hr
2. Bio chemical examinations – Lipid profile, Fasting and Random blood Sugar, Serum Albumin, Albumin/Globulin ratio
3. Liver function test - SGOT, SGPT, Direct, Indirect & Total Bilirubin & Serum alkaline phosphatase, Prothrombin Time
4. Kidney function test (Urea, Creatinine & Uric acid)
5. HbA1C Test.
6. Urine – Routine & Microscopic examination.
**POSOLOGY:**
**Group A: *Chankaraman* 6 km with Placebo Capsule**
| | |
| --- | --- |
|Drug
Placebo capsule
|Dose
Two Capsule(500mg) of Suji powder
|*Anupan*
Luke warm water
|*Kala*
Before meal twice morning an evening
|*Chankraman*
3 km in Morning and 3 km in Evening
|Duration
8weeks
**Group B: *Khadiradi Ghanvati***
| | |
| --- | --- |
|Drug
*Khadiradi Ghanvati*
|Dose
Two *Ghanavati* (Each 500mg)
|*Anupan*
Luke warm water
|*Kala*
Before meal twice morning and evening
|Duration
8 weeks
**PATHYA-APATHYA:**
Avoid withholding of urges, smoking, sedentary lifestyle, day sleep, consumption of curd, meat of *Aanup Desh,* food prepared with new cereals and lentils as well as flours, excess sweet and sour and salty substances. Restrict heavy, fried, and oily food. Anti *kapha* diet. Proper fasting, use of old rice and wheat, *Yava, Patola, Lashuna, Shigru, Triphala, Guduchi* leaves, *Kapittha, Jambu, Haridra,* bitter gourd and fenugreek.
**CRITERIA OF WITHDRAWL:**
The participants will be allowed to withdraw from the clinical trial if there is any major ailment. Subject not responding to treatment or developing any serious adverse drug reaction of therapy will be withdrawal from the study.
**REPORTING OF ADR**:
Adverse drug reactions if observed in the patients will be registered and duly reported to ADR Cell (Pharmacovigilance cell of GAU).
**CONSENT PROCEDURE:**
Written informed consent/Assent from patients will be taken prior to the initiation of clinical study in the recruited patients with suitable provisions for withdrawal.
**FOLLOW UP:**
Follow up study will be carried out for one month after completion of the treatment. *Pathya- Apathya* and *Chankramana* will be continued during the follow up period, Medicine (if required) will be given from OPD of Kayachikitsa IPGT & RA Hospital Jamnagar.
**ASSESMENT CRIETERIA:**
Fasting Blood Plasma glucose. ≥7.0 mmol/l (126mg/dl) OR Post Prandial Blood Plasma glucose. ≥11.1 mmol/l (200mg/dl)
BMI ≥ 23 Kg/m2
**1*.******Ati Pipasa/Trishnadhikya***
| | | |
| --- | --- | --- |
|1
Drinking water 1.5 – 2.0 litre/24 hrs
0
|2
Drinking water 2.0 – 2.5 litre/24 hrs
1
|3
Drinking water 2.0 – 2.5 litre/24 hrs with *Mukh-Talu-Kanth Shosh*
2
|4
Drinking water > 2.5 litre/24 hrs with *Mukh-Talu-Kanth Shosh*
3
**2. Quantity of Urine**
| | | |
| --- | --- | --- |
|1
1.5 – 2.0 litre/24 hrs
0
|2
>2.0 ≤ 2.5 litre/24 hrs
1
|3
> 2.5 ≤3.0 litre/24 hrs
2
|4
> 3.0 litre/24 hrs
3
**3.** **Frequency of Urine**
| | | |
| --- | --- | --- |
|1
3 - 5 times / day, no or rarely at nights
0
|2
6 – 8 times / day, 1 – 2 times / nights
1
|3
9– 11 times / day, 3– 4 times / nights
2
|4
> 11 times / day, > 4 times / nights
3
**4*.******Kara-Pada Daha /Supti***
| | | |
| --- | --- | --- |
|1
No *Daha*
0
|2
*Kara-Pada Daha* /*Supti* intermittent
1
|3
*Kara-Pada Daha /Supti* continuous but not severe
2
|4
*Kara-Pada Daha /Supti* continuous and severe
3
**5. *Nidradhikya***
| | | |
| --- | --- | --- |
|1
Normal sleep, 6-8 hrs/24 hrs
0
|2
Sleep up to 8 hrs/24 hrs with *Angagaurava*
1
|3
Sleep up to 8 hrs/24 hrs with *Angagaurava* & *Jrimbha*
2
|4
Sleep up to 8 hrs/24 hrs with *Tandra*
3
|5
Sleep up to 8 hrs/24 hrs with *Angagaurava*&*klama*
4
**SUMMARY**
Theclinical study entitled as **“****Clinical study on *KhadiradiGhana Vati* and *Chankramana* in the management of *Madhumeha* (Type2 Diabetes)- An open Randomized Comparative Clinical Trialâ€** **was carried out with the following:**
Ø **Aim and Objective**
1. Tostudy the literature regarding the Type 2 Diabetes through modern medicine aswell as *Ayurvedic* point of view.
2. Toevaluate the efficacy of *Khadiradi Ghana Vati*and *Chankramana* in management of *Madhumeha*(Type 2 Diabetes).
**INTRODUCTION**
This study was undertaken on account of increasing Type 2 Diabetesmellitus in the country as well as globally. This study is an attempt todecline the incidence of *Madhumeha* usingvery simple exercise i.e. *Chankramana*.India has been projectedby WHO as the country with the fastest growing population of Diabetic patients.In Indiahas remained at 11.8% in past four years, according to the National Diabetesand Diabetic Retinopathy Survey report released by the Health & FamilyWelfare Ministry. Mainly lack of exercise, lifestyle changes and unhealthy foodhabits caused such a hike in *Madhumeha*.
**1.****CONCEPTUAL STUDY**
Theconceptual study included overall view of the disease and therapeutics from the*Ayurvedic* point of view as well as modern point of view. Historicalreview brings us the information about the disease since *Vedic Kala* andwork done by previous research workers. The disease review comprises anelaborate coverage on *Madhumeha* in the field of *Nidana, Poorvarupa,Rupa, Samprapti, Sadhyasadhyata, Chikitsa* and *Pathya*-*Pathya*.The disease review from modern point of view included definition,classification, insulin bio-synthesis, secretion and action, etiopathogenesis,complications and treatment of type 2 diabetes mellitus. Efforts have been madeon the basis of etiology, pathogenesis, signs and symptoms, complications andprognosis to correlate type 2 diabetes mellitus with *Madhumeha*.
**2.****DRUG REVIEW**
Inthe drug review, individual ingredients of *Khadiradi Ghana Vati* has beendescribed in detail with latest possible research information along with itstherapeutic properties. *Khadiradi Ghana Vati*contains *Khadira, Puga* and *Kadara.* Various aspects of *Chankramana* i.e indication, contraindications andbenefits of it in *Madhumeha* disease are thoroughly reviewed from *Samhitas* and modern science.
**3.** **PHARMACOGNOSTICALSTUDY**
Organolepticcharacters of powdered *Khadiradi Ghana Vati* showed light pinkish browncoarse powder with astringent taste, slightly aromatic odour and hard and roughtouch. Microscopic characters observed under microscope were cork cells, vesselelements, fibres and few stone cells of *Kadara*, cork cells, stone cells,rhomboid crystals and tannin contents of *Khadira, Puga* with trichomefragments that is simple and multicellular, parenchymal cells with browncontent, fragments of vascular tissues with spirally and annularly thickenedvessels.
**4.** **ANALYTICALSTUDY AND MICROBIOLOGY STUDY**
Theresult of loss on drying was in *Khadiradi Ghana Vati* is 16.67 % w/w. Thewater-soluble extract as well as alcohol soluble extract values are 30.63 %w/w andalcohol soluble extract 26.96 %w/w. Total Ash value of *Khadiradi Ghana Vati*is 6.10 %w/w. pH value of *Khadiradi Ghana Vati* was 6 and tablet hardnessis 3.83 kg/cm3. To authenticate drug quality during study microbiological studywas done that revealed that *Khadiradi Ghana Vati* has stability and freefrom any microbial contamination.
**5.** **CLINICALSTUDY**
40patients fulfilling the inclusion and exclusion criteria were selected for thestudy, from the OPD and IPD of *Kayachiktsa*department of I.P.G.T. & R.A. Hospital, Jamnagar irrespective of theirrace, religion, caste & sex.
**Diagnosticcriteria for the study:**
Thediagnostic assessment criteria was done based on signs and symptoms of *Madhumeha**Prabhuta Mutrata, Avila Mutrata,* *Kshudadikya*, *Atipipasa*, *Pindikodweshtana* and associated complaints such as *Kara Pada Daha*, *Kara Pada Supti*, *Swedadikya,**Malam Kayeshu,* *Netra Jihwa Shravana Upadeha,* *VisraShariragandha*, *Snigdha Gatrata*, *Nidraadhikya,* *Shithila Angata*, *Guru Gatrata*and *Sheeta Priyatwa.*.
**Objective crieteria:**1. FastingBlood Plasma glucose ≥7.0mmol/l (126mg/dl) or,
2. PostPrandial Blood Plasma glucose ≥11.1mmol/l (200mg/dl) or,
3. HbA1C≥6.5%.
Ø Studytype - Interventional
Ø Studydesign - An open labelled randomized controlled clinicaltrial
Ø Endpoint- - Efficacy
Ø Duration - 8 Weeks
Ø No.of groups - 2
Ø Samplesize - Group A (*Chankramana* 6 km with placebo capsule):20 patients
GroupB (*Khadiradi Ghana Vati*):20 patients
The effect was assessed on the basis of changes in subjectiveand objective parameters. Follow up study was carried out for one month aftercompletion of the treatment.
**6.****OBSERVATION**
Maximum number of patients wereafflicted to *Guru Guna* and *Snigdha Guna* (100%) along with faultydiet pattern like *Vishamashana* (80%) followed by *Samashana* (20%).90% patients in the study had no exercise and only 10%had daily exercise.Maximum number of patients had *Vatakaphaja* *Prakriti* (80%). The maximum 16 patients (40%)had duration of diabetes for 0-2 years, followed by 32.5% had diabetes for 2-5years,22.5% were having diabetes for 5-10 yrs. Only 5% had diabetes > 10 yrs. 47.5 % patients had family history ofDiabetes mellitus and 52.5% patients had no family history of Diabetes.
Majority of the patients were takingfood items which were having high glycemic index. These include *Dadhi*(97.5%), *Mamsa* (100%), *Payaha* (100%), *GudaVikrita* (100%),*Shleshmajanaka Ahara* (97.5%), *Mutrajanaka Dravya* (60%).
14 patients each from Group A and Group B had FBS < 200 mg/dL. 70%patients fell under this category. 27.5% patients had FBS level 201-300 mg/dL.6 patients from Group A and 6 from Group B. Only 2.5% patients had FBS > 300mg/dL.
**7.****Overalleffect of therapy**
Atthe end of study, all data were analyzed. From this, it was found that in group A 55% shows MarkedImprovement followed by 40% having Moderate Improvement and 5% shows MildImprovement. *Chankaramana*treatment is giving better result when used clinically. In Group B, *Khadiradi Ghana Vati* was given and 55% shows MarkedImprovement followed by 35% having Moderate Improvement and 10% shows MildImprovement.
Statistically both *Chankaramana*treatment and *KhadiradiGhana Vati* treatment are insignificant i.e. both type of treatment has equal effecton the *Madhumeha*. Clinically *Chankramana* gave better results ascompared to *KhadiraadiGhana Vati* in terms of subjective parameters of *Prabhutmutrata*, *Kshudadhikya*. *Atipipasa*, *Pindikodwestan*, *Kara pada Supti*, *Guru Gatrata*, *Nidraadhiky* and*. Snigdha/ Picchila Gatrata* but statisticallyinsignificant.
Clinically *KhadiraadiGhana Vati* gave better results as compared to *Chankraman* in terms of objectiveparameters of diabetic profile in terms of approximately 5% although *Chankramana*also reduce FBS, PPBS and HbA1C to significant level.
**Discussion**
Forbreaking of the *Samprapti* of *Madhumeha*, treatment should work atthe level of *Dhatwagni* and responding *Kapha Dosha* and*Medodhatu*. Most of the contents of drugs *Khadiradi Ghana Vati* was having *Pramehahara* propertydirectly acting on etiopathogenesis of *Madhumeha*. By *Khadira*, *Kadara*,and *Puga* this *Vati* is having *Tikta*-*Katu*-*Kashaya-Rasa*,and their *Laghu-Ruksha Guna*, *Ushna Virya*, *Katu Vipaka*and *Deepan-Paachan*. This might have corrected *Kapha Dushti* andremoves *Medodhatwagnimandya* which corrected *Medo Dhatu Dushti*.They also act on *Dosha Vishesha* i.e*. BahudravyaSleshma**,**DushyaVishesha*i.e. *Kleda.* The alleviation of *Kapha- Pitta* leads to removalof obstruction to path of *Vata* and *Tridosha Shamaka* drug alsoalleviates *Vata Dushti*, thus cause normal functioning of *Doshas* and*Dhatus.* Thus, *Samprapti Vightana* occurs and normal functioning of*Doshas* and *Dhatus* achieved which relieves the symptoms of *Madhumeha*.
*Chankramana* increases movement of *Vayu* in body. *Chankramana*decreases *Medovruddhi* by acting *Medodhatwagni* level, which in turn decreases *Prameha* andits related symptoms. *Chankramana* clears the channels (*Srotas**a*) and increases the perceptive power of organs. According to modernscience diet and exercise are the first come non- pharmacological action fortreatment of diabetes mellitus. *Chankramana* of *Shata Yojana* actin the same way as exercise does to the body. *Chankramana* helps inlowering the glucose level in the blood. *Chankramana* also maintains theblood pressure, hence prevent body from complications of diabetes mellitus. *Khadira* is having antioxidantproperties which act like free radical scavengers. They help in the regenerationof Beta cells of pancreas and thus help in deducing *Prameha*.
**8.****Conclusion**
The main *Nidana* of *Prameha*are lack of exercise and improper food habits. Excess food intake of *Ushna**, Snigdha* and *Guru* are the primal cause of this disease. *Chankramana* isan easy remedy for *Prameha*.
Ayurveda *Shamana Chikitsa* for *Prameha* with*Chankramana* and *Khadiradi Ghana Vati* is very useful to treat mild to moderatepersistent cases of diabetes mellitus which is very safe and cost-effectivetherapy. With long term use of the *Chankramana* and *Khadiradi Ghana Vati, Nidana Parivarjana* and with the modification in life style one can reduce theprevalence as well as morbidity due to diabetes mellitus and improve thequality of life in Patients.
**SUMMARY**
Theclinical study entitled as **“****Clinical study on *KhadiradiGhana Vati* and *Chankramana* in the management of *Madhumeha* (Type2 Diabetes)- An open Randomized Comparative Clinical Trialâ€** **was carried out with the following:**
Ø **Aim and Objective**
1. Tostudy the literature regarding the Type 2 Diabetes through modern medicine aswell as *Ayurvedic* point of view.
2. Toevaluate the efficacy of *Khadiradi Ghana Vati*and *Chankramana* in management of *Madhumeha*(Type 2 Diabetes).
**INTRODUCTION**
This study was undertaken on account of increasing Type 2 Diabetesmellitus in the country as well as globally. This study is an attempt todecline the incidence of *Madhumeha* usingvery simple exercise i.e. *Chankramana*.India has been projectedby WHO as the country with the fastest growing population of Diabetic patients.In Indiahas remained at 11.8% in past four years, according to the National Diabetesand Diabetic Retinopathy Survey report released by the Health & FamilyWelfare Ministry. Mainly lack of exercise, lifestyle changes and unhealthy foodhabits caused such a hike in *Madhumeha*.
**1.****CONCEPTUAL STUDY**
Theconceptual study included overall view of the disease and therapeutics from the*Ayurvedic* point of view as well as modern point of view. Historicalreview brings us the information about the disease since *Vedic Kala* andwork done by previous research workers. The disease review comprises anelaborate coverage on *Madhumeha* in the field of *Nidana, Poorvarupa,Rupa, Samprapti, Sadhyasadhyata, Chikitsa* and *Pathya*-*Pathya*.The disease review from modern point of view included definition,classification, insulin bio-synthesis, secretion and action, etiopathogenesis,complications and treatment of type 2 diabetes mellitus. Efforts have been madeon the basis of etiology, pathogenesis, signs and symptoms, complications andprognosis to correlate type 2 diabetes mellitus with *Madhumeha*.
**2.****DRUG REVIEW**
Inthe drug review, individual ingredients of *Khadiradi Ghana Vati* has beendescribed in detail with latest possible research information along with itstherapeutic properties. *Khadiradi Ghana Vati*contains *Khadira, Puga* and *Kadara.* Various aspects of *Chankramana* i.e indication, contraindications andbenefits of it in *Madhumeha* disease are thoroughly reviewed from *Samhitas* and modern science.
**3.** **PHARMACOGNOSTICALSTUDY**
Organolepticcharacters of powdered *Khadiradi Ghana Vati* showed light pinkish browncoarse powder with astringent taste, slightly aromatic odour and hard and roughtouch. Microscopic characters observed under microscope were cork cells, vesselelements, fibres and few stone cells of *Kadara*, cork cells, stone cells,rhomboid crystals and tannin contents of *Khadira, Puga* with trichomefragments that is simple and multicellular, parenchymal cells with browncontent, fragments of vascular tissues with spirally and annularly thickenedvessels.
**4.** **ANALYTICALSTUDY AND MICROBIOLOGY STUDY**
Theresult of loss on drying was in *Khadiradi Ghana Vati* is 16.67 % w/w. Thewater-soluble extract as well as alcohol soluble extract values are 30.63 %w/w andalcohol soluble extract 26.96 %w/w. Total Ash value of *Khadiradi Ghana Vati*is 6.10 %w/w. pH value of *Khadiradi Ghana Vati* was 6 and tablet hardnessis 3.83 kg/cm3. To authenticate drug quality during study microbiological studywas done that revealed that *Khadiradi Ghana Vati* has stability and freefrom any microbial contamination.
**5.** **CLINICALSTUDY**
40patients fulfilling the inclusion and exclusion criteria were selected for thestudy, from the OPD and IPD of *Kayachiktsa*department of I.P.G.T. & R.A. Hospital, Jamnagar irrespective of theirrace, religion, caste & sex.
**Diagnosticcriteria for the study:**
Thediagnostic assessment criteria was done based on signs and symptoms of *Madhumeha**Prabhuta Mutrata, Avila Mutrata,* *Kshudadikya*, *Atipipasa*, *Pindikodweshtana* and associated complaints such as *Kara Pada Daha*, *Kara Pada Supti*, *Swedadikya,**Malam Kayeshu,* *Netra Jihwa Shravana Upadeha,* *VisraShariragandha*, *Snigdha Gatrata*, *Nidraadhikya,* *Shithila Angata*, *Guru Gatrata*and *Sheeta Priyatwa.*.
**Objective crieteria:**1. FastingBlood Plasma glucose ≥7.0mmol/l (126mg/dl) or,
2. PostPrandial Blood Plasma glucose ≥11.1mmol/l (200mg/dl) or,
3. HbA1C≥6.5%.
Ø Studytype - Interventional
Ø Studydesign - An open labelled randomized controlled clinicaltrial
Ø Endpoint- - Efficacy
Ø Duration - 8 Weeks
Ø No.of groups - 2
Ø Samplesize - Group A (*Chankramana* 6 km with placebo capsule):20 patients
GroupB (*Khadiradi Ghana Vati*):20 patients
The effect was assessed on the basis of changes in subjectiveand objective parameters. Follow up study was carried out for one month aftercompletion of the treatment.
**6.****OBSERVATION**
Maximum number of patients wereafflicted to *Guru Guna* and *Snigdha Guna* (100%) along with faultydiet pattern like *Vishamashana* (80%) followed by *Samashana* (20%).90% patients in the study had no exercise and only 10%had daily exercise.Maximum number of patients had *Vatakaphaja* *Prakriti* (80%). The maximum 16 patients (40%)had duration of diabetes for 0-2 years, followed by 32.5% had diabetes for 2-5years,22.5% were having diabetes for 5-10 yrs. Only 5% had diabetes > 10 yrs. 47.5 % patients had family history ofDiabetes mellitus and 52.5% patients had no family history of Diabetes.
Majority of the patients were takingfood items which were having high glycemic index. These include *Dadhi*(97.5%), *Mamsa* (100%), *Payaha* (100%), *GudaVikrita* (100%),*Shleshmajanaka Ahara* (97.5%), *Mutrajanaka Dravya* (60%).
14 patients each from Group A and Group B had FBS < 200 mg/dL. 70%patients fell under this category. 27.5% patients had FBS level 201-300 mg/dL.6 patients from Group A and 6 from Group B. Only 2.5% patients had FBS > 300mg/dL.
**7.****Overalleffect of therapy**
Atthe end of study, all data were analyzed. From this, it was found that in group A 55% shows MarkedImprovement followed by 40% having Moderate Improvement and 5% shows MildImprovement. *Chankaramana*treatment is giving better result when used clinically. In Group B, *Khadiradi Ghana Vati* was given and 55% shows MarkedImprovement followed by 35% having Moderate Improvement and 10% shows MildImprovement.
Statistically both *Chankaramana*treatment and *KhadiradiGhana Vati* treatment are insignificant i.e. both type of treatment has equal effecton the *Madhumeha*. Clinically *Chankramana* gave better results ascompared to *KhadiraadiGhana Vati* in terms of subjective parameters of *Prabhutmutrata*, *Kshudadhikya*. *Atipipasa*, *Pindikodwestan*, *Kara pada Supti*, *Guru Gatrata*, *Nidraadhiky* and*. Snigdha/ Picchila Gatrata* but statisticallyinsignificant.
Clinically *KhadiraadiGhana Vati* gave better results as compared to *Chankraman* in terms of objectiveparameters of diabetic profile in terms of approximately 5% although *Chankramana*also reduce FBS, PPBS and HbA1C to significant level.
**Discussion**
Forbreaking of the *Samprapti* of *Madhumeha*, treatment should work atthe level of *Dhatwagni* and responding *Kapha Dosha* and*Medodhatu*. Most of the contents of drugs *Khadiradi Ghana Vati* was having *Pramehahara* propertydirectly acting on etiopathogenesis of *Madhumeha*. By *Khadira*, *Kadara*,and *Puga* this *Vati* is having *Tikta*-*Katu*-*Kashaya-Rasa*,and their *Laghu-Ruksha Guna*, *Ushna Virya*, *Katu Vipaka*and *Deepan-Paachan*. This might have corrected *Kapha Dushti* andremoves *Medodhatwagnimandya* which corrected *Medo Dhatu Dushti*.They also act on *Dosha Vishesha* i.e*. BahudravyaSleshma**,**DushyaVishesha*i.e. *Kleda.* The alleviation of *Kapha- Pitta* leads to removalof obstruction to path of *Vata* and *Tridosha Shamaka* drug alsoalleviates *Vata Dushti*, thus cause normal functioning of *Doshas* and*Dhatus.* Thus, *Samprapti Vightana* occurs and normal functioning of*Doshas* and *Dhatus* achieved which relieves the symptoms of *Madhumeha*.
*Chankramana* increases movement of *Vayu* in body. *Chankramana*decreases *Medovruddhi* by acting *Medodhatwagni* level, which in turn decreases *Prameha* andits related symptoms. *Chankramana* clears the channels (*Srotas**a*) and increases the perceptive power of organs. According to modernscience diet and exercise are the first come non- pharmacological action fortreatment of diabetes mellitus. *Chankramana* of *Shata Yojana* actin the same way as exercise does to the body. *Chankramana* helps inlowering the glucose level in the blood. *Chankramana* also maintains theblood pressure, hence prevent body from complications of diabetes mellitus. *Khadira* is having antioxidantproperties which act like free radical scavengers. They help in the regenerationof Beta cells of pancreas and thus help in deducing *Prameha*.
**8.****Conclusion**
The main *Nidana* of *Prameha*are lack of exercise and improper food habits. Excess food intake of *Ushna**, Snigdha* and *Guru* are the primal cause of this disease. *Chankramana* isan easy remedy for *Prameha*.
Ayurveda *Shamana Chikitsa* for *Prameha* with*Chankramana* and *Khadiradi Ghana Vati* is very useful to treat mild to moderatepersistent cases of diabetes mellitus which is very safe and cost-effectivetherapy. With long term use of the *Chankramana* and *Khadiradi Ghana Vati, Nidana Parivarjana* and with the modification in life style one can reduce theprevalence as well as morbidity due to diabetes mellitus and improve thequality of life in Patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
- Patients of both male and female sexes from age group 20-60 years.
- Signs and symptoms of Madhumeha.
- Fasting Blood Plasma glucose.
- ≥7.0mmol/l (126mg/dl) OR Post Prandial Blood Plasma Glucose ≥11.1mmol/l (200mg/dl).
- BMI ≥ 23 Kg/m2 to 30 Kg/m2 5.
- Diagnosed cases who are not practicing 6 km regular walk.
- Patients of Diabetes mellitus receiving Insulin.
- Patients having chronic complications of Diabetes mellitus.
- Micro vascular Retinopathy, Neuropathy and Nephropathy Macro vascular Coronary artery disease, Peripheral vascular disease & Cerebro-vascular disease.
- Pregnant and lactating women.
- Tuberculosis and HIV.
- Patients with Prameha Pidika (carbuncle, furuncles, abscess).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement will be assessed on the basis of 8 weeks relief found in cardinal symptoms of disease 8 weeks Progress in the signs and symptoms based on 8 weeks the standard pattern will be applied before and 8 weeks after treatment 8 weeks
- Secondary Outcome Measures
Name Time Method Improvement will be assessed on the basis of relief found in cardinal symptoms of disease
Trial Locations
- Locations (1)
IPGT and RA Hospital Jamnagar Gujrat
🇮🇳Jamnagar, GUJARAT, India
IPGT and RA Hospital Jamnagar Gujrat🇮🇳Jamnagar, GUJARAT, IndiaPankaj KaushikPrincipal investigator9015190636dr.kaushik8286@gmail.com