A clinical trial to study effect of Darvyadi yoga in patients of Madhumeha (Type 2 Diabetes Mellitus).

Phase 3

Recruiting

• Conditions: patients of Type 2 Diabetes Mellitus

• Registration Number: CTRI/2018/01/011123
• Lead Sponsor: Ch Brahm Prakash Ayurved Charak Sansthan

Brief Summary

*Madhumeha* is a type of *vataj prameha*. *Prameha* are a list of urinary disorders, especially characterized by profuse urination with several abnormal qualities due to *dosha* imbalances. Morbidity and mortality must have been very high due to *madhumeha* in the past therefore it is enlisted among ‘*Ashta mahagada*in *charak samhita.* *Madhumeha* has been extensively described in ayurvedic texts of all times including *brihatrayi* and *laghutrayi.* Ayurvedic remedies for *madhumeha* are the oldest among all the available therapies, which includes in *prameha* category. These therapies involve *shamana, shodhana,* diet and life style changes and *yoga* in a number of forms with vivid variety of drugs. In parlance to diabetes a lot is yet unexplored in understanding and treatment of *Madhumeha* in light of Ayurveda. *Darvyadi yoga* is mentioned in Charak Samita Chikitsha sthana chapter 6/26. Contents of drug are *Devdaru, Daruharidra, Musta* and *Triphala*. India has gained status of potential epidemic with more than 62 million Diabetic individuals. India has been projected by World Health Organization as the country with fastest growing population of diabetic patients. There is no authentic, standardized drug/ drugs developed by Ayurveda followers or researchers so far which can decline the elevated blood sugar level. This research work aims at studying *Madhumeha* for its etiopathogenesis and management in parlance to Type 2 Diabetes Mellitus.

**Assessment Criteria :**

Objective parameters like FBS, PPBS, HbA1c and others will be assessed by laboratory investigations before and after treatment.

Subjective improvement in the patient will be assessed by adopting suitable scoring methods.

**Study Type:**Randomized Comparative clinical trial

**Study time:** 2 years

**Intervention time:** 60 days

**Sample size:** 120 (60 in each group)

**Group A:** Darvyadi yoga 1 gm TDS before meal, Exercise, Yoga and fixed diet regimen

**Group B:**Exercise, Yoga and fixed diet regimen

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Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-02
• Last Update Posted: 2018-02-08

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patients with Fasting Blood Sugar >126mg/dl and < 200 mg/dl.
• Patient with Post Prandial Blood Sugar >200mg/dl and < 350mg/dl.
• Patients with classical signs and symptoms of type 2 diabetes with Random Blood Sugar > 200mg/dl and < 300mg/dl.
• Patients with HbA1c > 6.5% and <10%.
• Patient recently diagnosed (for less than 3 months) as diabetic and not taking any medication.
• Patients willing to participate in study, to follow given instructions and give informed consent for a period of 60 days.

Exclusion Criteria

• 1.Patients aged below 30 years and above 65 years.
• 2.Patients with Fasting Blood Sugar > 200mg/dl.
• 4.Patients with Random Blood Sugar > 300mg/dl.
• 5.Patients with type 1 diabetes mellitus, uncontrolled type 2 diabetes mellitus and secondary diabetes.
• 6.Drug induced Diabetic patients, due to endocrinopathies (Acromegaly, Cushing’s syndrome).
• 7.Patients on prolonged medications with antidepressants etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Relief in cardinal signs & symptoms of patients.	60 days
2.Decrease in elevated levels of FBS, PPBS, HbA1c, Lipid profile, and other bio chemical parameters.	60 days

Secondary Outcome Measures

Name	Time	Method
1.Aetiopathogenesis of Madhumeha will be assessed by adopting suitable scoring methods.	2.Subjective improvement in the patient will be assessed by adopting suitable scoring methods.

Trial Locations

Locations (1)

Ch. Brahm Prakash Ayurved Charak Sansthan Hospital; 🇮🇳 Delhi, DELHI, India

Ch. Brahm Prakash Ayurved Charak Sansthan Hospital

🇮🇳Delhi, DELHI, India

Dr Umesh Kumar Sapra

Principal investigator

8368608139

umeshsapra123@gmail.com