A Randomised Controlled Trial To Evaluate The Efficacy Of Kampilladi Churna In The Management Of Madhumeha W.S.R. To Diabetes Mellitus Type II.

Ayurvedic remedies for Madhumeha(Diabetes mellitus) are the oldest among all the available therapies, which includes in the prameha category. Pramehas are a list of urinary disorders, especially characterized by profuse urination with several abnormal qualities due to doshik imbalancesP rameha has been mentioned that it is a group of disorders in which there is an increased frequency of micturition, the volume of urine is also increased, and the urine becomes turbid. Acharyas have explained that in Madhumeha there is vitiation of Vata Kapha Pradhana Tridosha associated with Meda and other Dhatus along with Ojas as Dushya which comes out of the body through Mutravaha Srotas.

A similar disease has been described in modern medical sciences as Diabetes Mellitus type 2 .Ramchandran A (2012)Diabetes Mellitus (DM) refers to a group of metabolic disorders characterized by chronic hyperglycaemia, polyuria, polydipsia, polyphagia, emaciation, and weakness due to disturbance in carbohydrate, fat and protein metabolism associated with a relative or absolute deficiency in insulin secretion, insulin action or both

Diabetes mellitus is defined as a disturbance of intermediary metabolism manifesting as chronic sustained hyperglycemia primarily due to either an absolute or relative lack of insulin. W.H.O Consultation (2014)has classified Diabetes mellitus in Four types .Although the prevalences of Type 2 Diabetes mellitus is increasing worldwide than Type 1, Prevalence rate of Diabetes Mellitus In India is 11.3% with (95% type II DM)

Rationale of Study

Rationale of study

Now a days due to sedentary lifestyle, junk food consumption and lack of exercise, all this factor hampers metabolism and as a result people are suffering from Diabetes and young generation are at risk of getting Diabetes.The most important thing is ,oral hypoglycemic agents have side effects like sudden hypoglycemia, gastro intestinal tract upset etc Moreover these drugs corrects only hyperglycemia and not the basic pathology ,these drugs prevent further progress of disease and in spite ,patients lands into life threatening complications and therefore there is need of safe and natural remedy.

Kampilladi churna is taken up for the present study because no study was carried out in the management of Madhumeha, drugs required for the preparation of churna are easily available, socio economic and method for preparation of churna is very easy. It does not contain any preservatives, can be easily taken by patient.

Study methodology

Type of study – Randomized Controlled Trial.

Location of study - OPD  department of Kayachikitsa.

Duration of Study - 18 months after approval of synopsis.

Duration of treatment –90 days. Last assessment – on 90 th day

Study setting

Total no of pts-70

Group A – Kampilladi Churna with 35 number of patients. (trial group) BD (before meal) 5GM twice a day with ushnodaka as anupan

Group B –Vallipanchamool Churna with 35 number of patients. ( control group)BD ( before meal ) 5GM twice a day****with ushnodaka as anupan

Follow up after every 15 days [0th, 15th, 30th, 45th,60th ,75th ,90th day] Final assessment of patient on 90 th day.

Patients suffering from lakshanas of Madhumeha in the age group of 30 years to 70 years, as they visit OPD  of Kayachikitsa department will be studied randomly irrespective of sex, religion, educational and economic status. Pathya(Ahara and Vihar regimen) -Proper diabetic diet pathya (ahara and vihara regimen)will be advised to the patients.

Subjective Parameters -1) Mukhamadhurya(sweetness in mouth)     2) Karpadasupti(numbness in palm and foot)    3) Dantadinammaladhikya(infection)     ] 4) Nidradhikya(excess sleep)     5) Pipasavriddhi(polydipsia)

6. Mutradhikya(polyuria)[      7) Swedadhikya(excess perspiration)      8) Karpadadaha(burning sensation in palm and foot)    9) Alasya(general debility)    10) Kshudhadhikya (increase in appetite)    11) Daurbalata (weakness)

Ojective parameters

1)RBS and PBS Every 15 th days

Day 1 -0th day -1st asssessment

1 st Follow up - will be on 15 thday.

2 nd Follow up – will be on 30 th day.

3 rd Follow up - will be on 45th day.

4 th follow up- will be on 60th day.

5 th follow up- will be on 75th day.

6th last  follow up- will be on 90th day.

2)HbA1C At 0th day and 90th day

Identification of drug - It will be done in Dravyaguna department of study Centre.

Standardization - Standardization will be made from Rasashastra department of Study after preparation of drug before the clinical trials will be conducted.

The drugs will be prepared as stated by Kampilladi Churna as per chakradutta and Vallipanchamool churna as per reference of Sushrutsamhita.

PATHYA ( Ahara and Vihara regimen)  Ahara- [] Patients should follow the following ahara: Moong, Chana, Gehu, Satu, Nachni, Karela, old grains.

Others-Dhani, laja/murmura ,maricha ,saindhava ,hingu ,haridra ,adraka

Vihar-  Upto 45 minutes of aerobic exercise per day will be advised to the patients .

1. Vyayama -Which includes brisk walking ,jogging, bicycling, swimming

2)Kreeda(games).playing badminton and tennis.

3)Yoga

Vallipanchmoola Churna         Guduchi-1part

Vidari -1part

Sariva -1part

Rajani -1part

Ajashringi-1part

Kampilladi Churna           Kampillaka-1part

Kutaj- 1part -

kapittha-1part

saptaparna-1part

shal-1part

Rohitak -1part

Bibhitak-1part

Conclusion will be drawn on overall assessment, tabulation, statistical analysis and graphic presentation of data

After applying statistical test to data results will be generated

And Results will be published .