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Clinical Trials/CTRI/2021/06/034054
CTRI/2021/06/034054Not yet recruitingPhase 2

AN OPEN LABEL DOUBLE ARM STUDY TO COMPARE THE EFFECT OF UDVARTANA TRIKANTAKADI GHRITA SHODHANANGA SNEHAPANA VIRECHANA KARMA ALONE AND WITH KADARAKRAMUKA KASHAYA IN STHULA MADHUMEHA VIS A VIS TYPE2 DIABETES MELLITUS

DR BINDUSHREE N1 site in 1 country40 target enrollmentStarted: June 23, 2021Last updated:

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
To compare the therapeutic effect of udwartana trikantakadi grutha shodhananga snehapana followed by virechana karma alone and udwartana trikantakadi grutha shodhananga snehapana followed by virechana karma and kadara kramuka kashaya in sthula madhumeha vis a vis type 2 diabetes mellitus

Study Overview

Brief Summary

India has more number of diabetic subjects than any other country and   being termed as

Diabetes capital of the world. According to WHO diabetes mellitus is the 7th leading cause of death and more than 69 million people living with diabetes in India out of a worldwide total 415 million By considering the alarming growth in incidence of diabetes mellitus it is a need of hour to adopt better treatment protocol. In Ayurveda treatment put emphasizes on the basis of bala. Sushruthahas explained two types of Prameha,Sthula and krushaPrameha. Among which the present study is signifying on Sthulaprameha

Udvartana as Poorvakarma is necessary in madhumehabecause of involvement of BhuriShleshma Sthulamadhumeha being apathyanimittaja and kleda  Pradhana vyadhi Shodhana is the line of treatment and here we are adopting Shodhana in the form of Virechana

Shodhana in Madhumeha should be done after giving Snehana with trikanatakadi ghrita kadara and kramuka are having kapha pittahara and medhogna property and also Sushrutha mentioned kadarakramukakashaya in   madhumeha

Therefore  the present study will be done to compare the effect of Udvartana poorvaka trikantakadighrita shodhananga Snehapana Virechanakarma and Udvartanapoorvaka trikantakadighrita shodhanangasnehapana Virechanakarma followed by kadarakramuka kashaya in sthulamadhumeha vis a vis type 2 Diabetes mellitus

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Open Label

Eligibility Criteria

Ages
30.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Subjects presenting with the Lakshanas of Sthula Madhumeha Subjects presenting with the signs and symptoms of type 2 Diabetes mellitus Subjects of either gender in between the age group 30 to 70 years Subjects fit for Udvartana Karma Subjects fit for Snehapana Subjects fit for Virechana Karma FBS > 126mg per dl PPBS > 200mg per dl.

Exclusion Criteria

  • Subjects with Juvenile Diabetes Gestational Diabetes Type 1 Diabetes Mellitus and any other systemic diseases which may interfere with the course of treatment.

Outcomes

Primary Outcomes

To compare the therapeutic effect of udwartana trikantakadi grutha shodhananga snehapana followed by virechana karma alone and udwartana trikantakadi grutha shodhananga snehapana followed by virechana karma and kadara kramuka kashaya in sthula madhumeha vis a vis type 2 diabetes mellitus

Time Frame: 45 to 50 days

Secondary Outcomes

  • To compare the therapeutic effect of udwartana followed by virechana karma and kadarakramuka kashaya in sthula madhumeha(50 to 55 days)

Investigators

Sponsor
DR BINDUSHREE N
Sponsor Class
Other [Self sponsored]

Study Sites (1)

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