A RANDAOMIZED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF PATHYA, SHODHANA, SHAMANA AND RASAYANA CHIKITSA IN THE MANAGEMENT OF MADHUMEHA W.S.R TO TYPE II DIABETES MELLITUS.

Phase 2

Not yet recruiting

• Conditions: Type 2 diabetes mellitus without complications,

• Registration Number: CTRI/2019/02/017755
• Lead Sponsor: SKAMC H RC

Brief Summary

MADHUMEHA IS EXPLAINED AS ONE AMONG THE VATAJA PRAMEHAS AND CHARACTERIZED BY MADHURYATA OF BOTH MUTRA AND SHARIRA.THE DISEASE MADHUMEHA EXPLAINED IN AYURVEDA IS SIMILAR TO DIABETES MELLITUS (DM). IN MODERNIZED ERA, THE SEDENTARY LIFE STYLE HAS ADVERSELY AFFECTED THE HOMEOSTASIS OF HUMAN BODY GIVING RISE TO VARIOUS LIFE STYLE DISEASES. DIABETES MELLITUS REFERS TO GROUP OF COMMON METABOLIC DISORDERS THAT SHARE THE PHENOTYPE OF HYPERGLYCEMIA. GLOBALLY, AS OF 2010, AN ESTIMATED 285 MILLION HAD DIABETES, WITH TYPE 2 MAKING UP ABOUT 90% OF CASES. IN 2013, ACCORDING TO INTERNATIONAL DIABETES FEDERATION, AN ESTIMATED 381MILLION PEOPLE HAD DIABETES AND ITS PREVALENCE IS INCREASING RAPIDLY, AND BY 2030, THIS NUMBER IS ESTIMATED TO BE DOUBLE. IT IS THE DISORDER, WHEN UNCONTROLLED MAY LEAD TO CLUSTER OF COMPLICATIONS LIKE RENAL FAILURE, NONTRAUMATIC LOWER EXTREMITY AMPUTATIONS AND ADULT BLINDNESS THEREBY AFFECT THE SOCIO - ECONOMIC STATUS.

AYURVEDA CLASSICS PROVIDE REFERENCES ON PATHYA AHARA VIHARA, SHODHANA KARMA AND VARIOUS HERBAL AND HERBO-MINERAL DRUGS WHICH CAN BE SAFELY USED IN MANAGEMENT OF DIABETES MELLITUS. MADHUMEHA IS ANUSHANGI VYADI AND IS SAID TO BE KRUCHRA SADHYA GIVING SCOPE FOR THE UTILIZATION OF RASAYANA DRAVYAS FOR THE TREATMENT. ACHARYA SHARANGADHARA GIVES GUDUCHI AS AN EXAMPLE WHICH HAS RASAYANA PROPERTY. FOR THE PURPOSE OF KLEDA NIRHARANARTHA SHODHANA IS ADVISED AS THE LINE OF TREATMENTFOR WHICH VIRECHANA KARMA CAN BE ADOPTED.

     THIS STUDY IS DOUBLE ARM OPEN LABELLED COMPARATIVE CLINICAL STUDY COMPARING THE EFFICACY OF PATHYA, SHODHANA KARMA, SHAMANA CHIKITSA AND RASAYANA CHIKITSA IN THE MANAGEMENT OF *MADHUMEHA.* WSR TO TYPE 2 DIABETES MELLITUS 90 DAYS  FOR 4 GROUPS WITH 50 PATIENTS IN EACH GROUP WHICH INCULDES THE CLASSICAL SIGN & SYMPTOMS OF MADHUMEHA. THIS STUDY WILL BE CONDUCTED IN SRI KALABYRAVESHWARA SWAMY AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER, BENGALURU, KARNATAKA.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-09
• Last Update Posted: 2019-02-13

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients presenting with the lakshanas of Madhumeha.
• Patients presenting the signs and symptoms of Type 2 Diabetes mellitus.
• Patients fit for Virechana Karma.

Exclusion Criteria

• 1.Patient with other systemic disorders which interferes with the course of treatment.
• 2.Pregnant and Lactating women.
• 3.Patients with Juvenile Diabetes, Type 1 Diabetes mellitus.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TO ASSESS THE ROLE AND RELEVANCE OF DIET AND TREATMENT (SHODHANA, SHAMANA AND RASAYANA) IN THE MANAGEMENT OF MADHUMEHA w.s.r TO TYPE 2 DIABETES MELLITUS.	90 days

Secondary Outcome Measures

Name	Time	Method
THE FINAL BENEFICIARIES WILL BE PATIENTS, RESEARCHERS AND AYURVEDIC PHYSICIANS	90 days

Trial Locations

Locations (1)

SKAMC H R C; 🇮🇳 Bangalore, KARNATAKA, India

SKAMC H R C

🇮🇳Bangalore, KARNATAKA, India

Dr Vijayalakshmi S

Principal investigator

9964815059

drviju.prati.09@gmail.com