| CTRI Number |
CTRI/2021/06/034054 [Registered on: 07/06/2021] Trial Registered Prospectively |
| Last Modified On: |
28/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
CLINICAL STUDY TO EVALUATE EFFICACY OF POWDER MASSAGE WITH MEDICATED DRUGS AND THERAPEUTIC PURGATION ALONE AND WITH KADARAKRAMUKA MEDICATED DECOCTION INTERNAL ADMINISTRATION TYPE 2 DIABETES MELLITUS |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NOT APPLICABLE |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR BINDUSHREE N |
| Designation |
POST GRADUATE SCHOLAR |
| Affiliation |
SKAMCH RC |
| Address |
DEPARTMENT OF PG STUDIES IN PANCHAKARMA SRI KALABYRAVESHVARASWAMY AYURVEDIC MEDICAL COLLEGE
RPC LAYOUT VIJAYANAGAR BANGLORE
SKAMCH RC RPC LAYOUT
VIJAYANAGAR
BANGLORE
Bangalore
KARNATAKA
560104
India |
| Phone |
9480545904 |
| Fax |
|
| Email |
bindhushreealur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR KIRAN M GOUD |
| Designation |
PROFFESSOR |
| Affiliation |
SKAMCH RC |
| Address |
DEPARTMENT OF PG STUDIES IN PANCHAKARMA SRI KALABYRAVESHVARASWAMY AYURVEDIC MEDICAL COLLEGE
RPC LAYOUT VIJAYANAGAR BANGLORE
DEPARTMENT OF PG STUDIES IN PANCHAKARMA SRI KALABYRAVESHVARASWAMY AYURVEDIC MEDICAL COLLEGE
RPC LAYOUT VIJAYANAGAR BANGLORE
Bangalore
KARNATAKA
560104
India |
| Phone |
9845109556 |
| Fax |
|
| Email |
kiranmgoud@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR KIRAN M GOUD |
| Designation |
PROFFESSOR |
| Affiliation |
SKAMCH RC |
| Address |
DEPARTMENT OF PG STUDIES IN PANCHAKARMA SRI KALABYRAVESHVARASWAMY AYURVEDIC MEDICAL COLLEGE
RPC LAYOUT VIJAYANAGAR BANGLORE
DEPARTMENT OF PG STUDIES IN PANCHAKARMA SRI KALABYRAVESHVARASWAMY AYURVEDIC MEDICAL COLLEGE
RPC LAYOUT VIJAYANAGAR BANGLORE
Bangalore
KARNATAKA
560104
India |
| Phone |
9845109556 |
| Fax |
|
| Email |
kiranmgoud@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Sri kalabyraveshwaraswamy ayurvedic medical college hospital and research center vijayanagara Bengaluru |
|
|
Primary Sponsor
|
| Name |
DR BINDUSHREE N |
| Address |
DEPARTMENT OF PG STUDIES IN PANCHAKARMA |
| Type of Sponsor |
Other [Self sponsored] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NOT APPLICABLE |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR KIRAN M GOUD |
Sri kalabyraveshwaraswamy ayurvedic medical college hospital and research centre |
Department of panchakarma
RPC LAYOUT PIPELINE ROAD VIJAYANAGAR BENGALURU
Bangalore
KARNATAKA |
9845109556
kiranmgoud@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SKAMCHRC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
udwartana followed by virechana karma
Duration 20 to 25 days |
Udwartana with triphala churna externally until samyak rookshana lakshana appears and followed by virechana karma with trivrut lehya internally |
| Comparator Agent |
udwartana followed by virechana karma and kadarakramuka kashaya internally |
udwartana with triphala churna externally until samyak rookshana lakshana appears followed by virechana karma with trivrut lehya and kadarakramuka kashaya intrenally for 30 days 24 ml twice daily after food
duration of study 50 to 55 days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
Subjects with Juvenile Diabetes Gestational Diabetes Type 1 Diabetes Mellitus and any other systemic diseases which may interfere with the course of treatment |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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 |
45 to 50 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the therapeutic effect of udwartana followed by virechana karma and kadarakramuka kashaya in sthula madhumeha |
50 to 55 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
23/06/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="1"
Days="27" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 |