| CTRI Number |
CTRI/2019/01/016842 [Registered on: 02/01/2019] Trial Registered Prospectively |
| Last Modified On: |
31/12/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [treatment] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF ROOKSHANA POORVAKA VIRECHANA KARMA AND ROOKSHANA POORVAKA GURU ATARPANA IN THE MANAGEMENT OF STHOULYA W.S.R TO OBESITY |
|
Scientific Title of Study
|
A Comparative Clinical Study to Evaluate the Efficacy Of Rookshana Poorvaka Virechana Karma and Rookshana Poorvaka Guru Atarpana in the Management of Sthoulya W S R to Obesity |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manjula |
| Designation |
PG Scholar |
| Affiliation |
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre |
| Address |
Sri Kalabyraveshwara Swamy Ayurvedic medical college hospital and research centre
No 10 Pipeline Road RPC layout Vijayanagar Bengaluru
Bangalore
KARNATAKA
560104
India |
| Phone |
9620362676 |
| Fax |
|
| Email |
manjulatukade79@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr vinaykumar K N |
| Designation |
Reader |
| Affiliation |
Sri Kalabyraveshwara Swamy Ayurvedic medical college hospital and research centre |
| Address |
Department of Panchakarma, Room No 01
Sri Kalabyraveshwara Swamy Ayurvedic medical college hospital and research centre
No 10 Pipeline Road RPC layout Vijayanagar Bengaluru
Bangalore
KARNATAKA
560104
India |
| Phone |
9845617690 |
| Fax |
|
| Email |
Knvgowda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjula |
| Designation |
PG Scholar |
| Affiliation |
Sri Kalabyraveshwara Swamy Ayurvedic medical college hospital and research centre |
| Address |
Department of Panchakarma, Room No 01
Sri Kalabyraveshwara Swamy Ayurvedic medical college hospital and research centre
No 10 Pipeline Road RPC layout Vijayanagar Bengaluru
Bangalore
KARNATAKA
560104
India |
| Phone |
9620362676 |
| Fax |
|
| Email |
manjulatukade79@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Manjula |
| Address |
SRI KALABYRAVESHWARA SWAMY AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr vinaykumar K N |
Sri Kalabyraveshwara Swamy Ayurvedic medical college hospital and research centre |
Department of Panchakarma, Room No 01
Sri Kalabyraveshwara Swamy Ayurvedic medical college hospital and research centre
No 10 Pipeline Road RPC layout Vijayanagar Bengaluru
Bangalore
KARNATAKA |
9854617690
Knvgowda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SKAMCH AND RC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GROUP A:Rookshana Karma then Virechana Karma |
GROUP A:Rookshana Karma with Kolakulatthadi Choorna and Triphala Choorna for 7 Days then Virechana Karma |
| Comparator Agent |
GROUP B: Rookshana Karma with Vyoshadhi Saktu |
GROUP B: Rookshana Karma with Kolakulatthadi Choorna and Triphala Choorna for 7 Days then Vyoshadhi Saktu For 15 Days |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient presenting with the lakshanas of Sthoulya as mentioned in the Ayurveda and Modern Literature.
Patient fit for Rookshana karma
Patient with BMI more than 25.
|
|
| ExclusionCriteria |
| Details |
Patient with other systemic disorders which interferes with the course of treatment
Pregnant and Lactating women
Patient aged less than 16 year and more than 60 year
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| EFFICACY OF INTERVENTION OVER SUBJECTIVE CRETIRIA OF STHOULYA |
22 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
Not applicable |
|
|
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)
|
07/01/2019 |
| 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="1"
Months="3"
Days="15" |
|
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)?
|
|
Brief Summary
|
STHOULYA COMES UNDER
THE HEADING OF MEDOROGA WHICH RESULT DUE
TO THE DYSFUNCTION .THE LAKSANAS OF STHOULYA CAN BE CORRELATED WITH
THE SYMPTOMS OF OBESITY. OBESITY AFFECTS ABOUT 13% OF THE ADULTS POPULATION(11%
OF MEN and 15% OF WEMEN) WERE OBESE IN 2016. THE WORLD WIDE PREVELANCE OF OBESITY HAS NEARLY TRIPLED
BETWEEN 1975 AND 2016. STHOULYA BEING
IDENTIFIED IN THE CATEGORY OF BAHU DOSHAVASTHA WHICH IS TO BE MANAGED BY
ADOPTION OF SHODHANA IN CHARAKA SAMHITA.UDVATANA HAS KAPHAHARA SHTIRIKARAM
ANGANAM , MEDASA PRAVILAYANA EFFECT AND TO BRING ABOUT ROOKSHANA EFFECT WHERE
ROOKSHANA IS TOLD TO BE DONE PRIOR TO SHODHANA ,SHODHANANGA SNEHAPANA WITH
MOORCHITA TAILA IS DONE WHERE AS VIRECHANA YOGA WITH TRIVRUT
LEHYA.ADMINISTRATION OF GURU CHA ATARPANA WHICH POSSESS THE PROPERTIES OF
VATAGHNA, KAPHAHARA, MEDONASHAKA ARE CONSIDERED AS AN IDEAL FAS SAMSHAMAN
THERAPY. THIS STUDY IS DOUBLE ARM OPEN LABELLED COMPARATIVE CLINICAL STUDY
COMPARING THE EFFICACY OF ROOKSHANA POORVAKA VIRECHANA KARMA AS 21 DAYS AND
ROOKSHANA POORVAKA GURU ATARPANA 22 DAYS FOR 20 PATIENTS IN EACH GROUP WHICH INCULDES
THE CLASSICAL SIGN & SYMPTOMS OF STHOULYA. THIS STUDY WILL BE CONDUCTED IN
SRI KALABYRAVESHWARA SWAMY AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER,
BENGALUR COMES UNDER
THE HEADING OF MEDOROGA WHICH RESULT DUE
TO THE DYSFUNCTION .THE LAKSANAS OF STHOULYA CAN BE CORRELATED WITH
THE SYMPTOMS OF OBESITY. OBESITY AFFECTS ABOUT 13% OF THE ADULTS POPULATION(11%
OF MEN and 15% OF WEMEN) WERE OBESE IN 2016. THE WORLD WIDE PREVELANCE OF OBESITY HAS NEARLY TRIPLED
BETWEEN 1975 AND 2016. STHOULYA BEING
IDENTIFIED IN THE CATEGORY OF BAHU DOSHAVASTHA WHICH IS TO BE MANAGED BY
ADOPTION OF SHODHANA IN CHARAKA SAMHITA.UDVATANA HAS KAPHAHARA SHTIRIKARAM
ANGANAM , MEDASA PRAVILAYANA EFFECT AND TO BRING ABOUT ROOKSHANA EFFECT WHERE
ROOKSHANA IS TOLD TO BE DONE PRIOR TO SHODHANA ,SHODHANANGA SNEHAPANA WITH
MOORCHITA TAILA IS DONE WHERE AS VIRECHANA YOGA WITH TRIVRUT
LEHYA.ADMINISTRATION OF GURU CHA ATARPANA WHICH POSSESS THE PROPERTIES OF
VATAGHNA, KAPHAHARA, MEDONASHAKA ARE CONSIDERED AS AN IDEAL FAS SAMSHAMAN
THERAPY. THIS STUDY IS DOUBLE ARM OPEN LABELLED COMPARATIVE CLINICAL STUDY
COMPARING THE EFFICACY OF ROOKSHANA POORVAKA VIRECHANA KARMA AS 21 DAYS AND
ROOKSHANA POORVAKA GURU ATARPANA 22 DAYS FOR 20 PATIENTS IN EACH GROUP WHICH INCULDES
THE CLASSICAL SIGN & SYMPTOMS OF STHOULYA. THIS STUDY WILL BE CONDUCTED IN
SRI KALABYRAVESHWARA SWAMY AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER,
BENGALURU KARNATAKA |