Roll of ayurveda medicine in the management of Madhumeha (Diabetes)
- Conditions
- Type 2 diabetes mellitus without complications,
- Registration Number
- CTRI/2019/07/020363
- Lead Sponsor
- National Institute of Ayurveda
- Brief Summary
INTRODUCTION
*Ayurveda* is science of life as it explains (the conditions of) the life. The purpose of science of life is maintenance of the health and alleviation of disease, of one that is ailing. This science of treatment is taught for the benefit of life.
As life in the modern era has becomes more commercialized and mechanical. The tendencies of a person has been changed a lot with respect to himself that’s why the lifestyle disorders like heart disease, diabetes, cancer etc. are now mostly seen. Incurable and chronic diseases are increasing in the society because of irregular diet pattern and stress conditions; one of them is *Madhumeha*, Which is mentioned in classical *Ayurvedic* texts. It can be co-related with DM (diabetes mellitus), which is a growing health hazard in developing countries like India.
*Madhumeha* is a type of 20 type of *Premeha* .Which come under type of *Vataj Prameha* . The *Samprapti* (pathogenesis) and *Nidan* was described in *Charaka Samhita Nidan 4* and the *Chikitsa* of *madhumeha* described in *ch.chi.6*. In ch.*chi.6/34* “***सिदà¥à¤§à¤¾à¤¨à¤¿*** ***तैलानि*** ***घृतानि चैव देयानि मेहेषà¥à¤µà¤¨à¤¿à¤²à¤¾à¤¤à¥à¤®à¤•à¥‡à¤·à¥***…†*Charaka* described that due to the dominance of *vata* in *madhumeha* medicated *sneha* should be use for getting better result because *sneha* is best remedy for *vata* .So i choose to internal use of *madhumehari ghrit* in the management of *madhumeha* .The *ghrit* will be prepaired with *madhumehari churna* which is attested and estabilished drug in *madhumeha*.
*Madhumeha* is a type of 20 type of *Premeha* .Which come under type of *Vataj Prameha* . The *Samprapti* (pathogenesis) and *Nidan* was described in *Charaka Samhita Nidan 4* and the *Chikitsa* of *madhumeha* described in *ch.chi.6*. In ch.*chi.6/34* “***सिदà¥à¤§à¤¾à¤¨à¤¿*** ***तैलानि*** ***घृतानि चैव देयानि मेहेषà¥à¤µà¤¨à¤¿à¤²à¤¾à¤¤à¥à¤®à¤•à¥‡à¤·à¥***…†*Charaka* described that due to the dominance of *vata* in *madhumeha* medicated *sneha* should be use for getting better result because *sneha* is best remedy for *vata* .So i choose to internal use of *madhumehari ghrit* in the management of *madhumeha* .The *ghrit* will be prepaired with *madhumehari churna* which is attested and estabilished drug in *madhumeha*.
NEED OF STUDY
As the *madhumeha* is burning problem today there is need to study deeply and implement the *Ayurvedic* principles in treatment of *madhumeha* as there are no side effects.
*Ayurvedic* treatment is of less value, without knowing its exact cause, as *Samprapti Vighatana* can only be done when we know its cause and how the patho-physiology happens.
**Hypothesis:-**
**Null hypothesis:-** The effect of *Madhumehari Churna* equal with *Madumehari Ghrit*.
**Alternetive hypothesis:-** Either *Madhumehari Ghrit* effectiveness more or less than *Madhumehari Churna.*
**AIMS & OBJECTIVES**
To evaluate the effect of *Madhumehari Ghrit* in the management of madhumeha.
To compare the effect of *Madhumehari Ghrit* and standard drug *Madhumehari* *churna* .
**MATERIALS AND METHODS**
**Materials:-**
For present study two types of materials will be utilized as categorized below.
1.Literary material: - Reference will be collected from classical *Ayurvedic* texts as well from previous research works/thesis, research articles from internet and modern science texts to explain fundamental principles.
2.Clinical material: - clinical study will be done on the patients of *Madhumeha* in two groups to fulfill the above said objectives.
A. Patient:- Patient fulfilling all the selection criteria, visiting OPD, IPD of NIA and Bombaywala hospital, Jaipur.
B. Laboratory:- Assistance will be taken from central lab of NIA, Jaipur.
C. **Drug**:- Drug will be purchased and prepared through pharmacy of NIA, Jaipur.
**METHODS**
The main criteria of diagnosis of the patient will be based on the cardinal and associated signs, symptoms and investigations of the disease based on the *Ayurvedic* and modern texts.
**CLINICAL STUDY**
A clinical study will be done as under -
**Administration of Drug**
40 clinically diagnosed patients will be randomly divided into 2 Groups of 20 each as below:-
**In first group** 20 patients will be administered *Madhumehari churna* in the dose of 5 gms. before meal 2 times a day with water for 2 months.
**In second group** 20 patients will be administered *Madhumehari Ghrit* in the dose of
*6 grams* before meal 2 times a day with lukewarm water for 2 months.
**Criteria for the assessment:**
The effect of trial drug will be assessed in terms of Subjective & Laboratory parameters
****Subjective assessment****-****
All the patients registered for clinical trial will be asked for any changes in their clinical manifestations.
******Objective assessment-******
1.Blood sugar level – Fasting and Post prandial.
2.Lab investigations- CBC, E.S.R.
3.Urine test for blood sugar in urine.
4.Lipid profile.
These investigations will be carried out for the diagnosis of *Madhumeha* and to exclude any other systemic complications.
**DURATION**-
For 2 months
**DIRECTION AND DIET*****-***
As mentioned in classical *Ayurvedic* text.
**FOLLOW UP*****-***
All the patients will be reviewed after each 15 days for a period of 2 months. During the trial and follow up study the patients will be assessed on the basis of following parameters-
1. Subjective improvement
2. Objective improvement
**Subjective improvement**
All the patients registered for the present trial will be looked for any improvement in the symptoms mentioned in *Ayurveda* and modern texts and changes in their health. if any, produced after the course of therapy.
1. **Objective improvement**
Various signs mentioned in *Ayurveda* texts and modern sciences will be looked into for any imprvement after the course of therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 40
- 1.Presence of cardinal symptoms of Madhumeha described in Ayurveda texts.
- 2.Confirmed cases of DM type II on the basis of laboratory investigations.
- 3.Patients having F.B.S. level ranges between 110 – 150 mg/dl and P.P. B.S. between 141 – 200 mg/dl.
- 1.Patient having age below 20 and above 70 years.
- 2.Patient suffering from complication of DM.
- 3.Patient having Type-I DM (IDDM).
- 4.Patient having Type-II DM with any other serious systemic disease.
- 5.Patient having a FBS more than 150 mg/dl and PPBS more than 200 mg/dl.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the effect of Madhumehari Ghrit in the management of madhumeha 2 MONTH
- Secondary Outcome Measures
Name Time Method 1.To compare the effect of Madhumehari Ghrit and standard drug Madhumehari churna . 2 MONTH
Trial Locations
- Locations (1)
NATIONAL INSTITUTE OF AYURVEDA
🇮🇳Jaipur, RAJASTHAN, India
NATIONAL INSTITUTE OF AYURVEDA🇮🇳Jaipur, RAJASTHAN, IndiaPRADEEPPrincipal investigator8318802228rajpradeep74@gmail.com