| CTRI Number |
CTRI/2021/04/032623 [Registered on: 07/04/2021] Trial Registered Prospectively |
| Last Modified On: |
05/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Panchakarma] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
EFFICACY OF VIRECHANA AND UDWARTANA KARMA IN THE MANAGEMENT OF STHAULYA (OBESITY) |
|
Scientific Title of Study
|
EFFICACY OF VIRECHANA KARMA AND UDWARTANA KARMA IN THE MANAGEMENT OF STHAULYA (OBESITY) AN OPEN LABELED RANDOMIZED COMPARATIVE CLINICAL TRIAL |
| Trial Acronym |
VUS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Urvashi Patel |
| Designation |
MD (AYU) Scholar |
| Affiliation |
Government Akhandanand Ayurved Mahavidyalaya |
| Address |
Department of Panchakarma, Government Akhandanand Ayurved Mahavidyalaya, Bhadra, Ahmedabad
Departement of Panchakarma, Government Akhandanand Ayurved Mahavidyalaya, Bhadra, Ahmedabad
Ahmadabad
GUJARAT
380001
India |
| Phone |
8320889714 |
| Fax |
|
| Email |
urvashipatel2991@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Falgun Patel |
| Designation |
Reader |
| Affiliation |
Government Akhandanand Ayurved Mahavidyalaya |
| Address |
Department of Panchakarma, Government Akhandanand Ayurved Mahavidyalaya, Bhadra, Ahmedabad
Departement of Panchakarma, Government Akhandanand Ayurved Mahavidyalaya, Bhadra, Ahmedabad
Ahmadabad
GUJARAT
380001
India |
| Phone |
8320889714 |
| Fax |
|
| Email |
vdfalgun@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Urvashi Patel |
| Designation |
MD (AYU) Scholar |
| Affiliation |
Government Akhandanand Ayurved Mahavidyalaya |
| Address |
Department of Panchakarma, Government Akhandanand Ayurved Mahavidyalaya, Bhadra, Ahmedabad
Departement of Panchakarma, Government Akhandanand Ayurved Mahavidyalaya, Bhadra, Ahmedabad
GUJARAT
380001
India |
| Phone |
8320889714 |
| Fax |
|
| Email |
urvashipatel2991@gmail.com |
|
|
Source of Monetary or Material Support
|
| Akhandanand Ayurved Mahavidyalaya, Bhadra, Ahmedabad |
|
|
Primary Sponsor
|
| Name |
Government Akhandanand Ayurved Mahavidyalaya |
| Address |
Government Akhandanand Ayurved Mahavidyalaya, Bhadra, Ahmedabad |
| Type of Sponsor |
Other [Government Ayurvedic college and Hospital] |
|
|
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 |
| Urvashi Patel |
Government Akhandanand Ayurved Mahavidyalaya, Bhadra, Ahmedabad |
Government Akhandanand Ayurved Mahavidyalaya, Bhadra, Ahmedabad
Ahmadabad
GUJARAT |
8320889714
urvashipatel2991@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, Government Akhandanand Ayurved Mahavidyalaya, Bhadra, Ahmedabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: Sthaulya, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Udwartana Karma |
Yava Churna (Hordeum vulgare Linn. /Barley powder) for 21 days |
| Intervention |
Virechana Karma |
Virechana will be done by Ichhabhedi Rasa -
(4-6 tablet, each tablet 125mg)
Anupana: Sharkara Yukta Jala (10gm Sharkara + 200 ml water)
At Shleshma Kale Gate
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients between the age group of 18 to 60 years with classical signs and symptoms of Sthaulya.
Patients having BMI (Body Mass Index) greater and equal to 25 and less than equal to 35 will be taken for the study.
In Shodhana group Virechana Yogya as per Ayurvedic Classic will be included.
|
|
| ExclusionCriteria |
| Details |
Patients having age less than 18 and greater than 60 will be excluded.
Known case of serious Cardiac, Renal or Hepatic diseases, Hypertension, AIDS, STD, TB etc. Obesity due to drugs e.g. Anticonvulsant, Antipsychotics, Beta-blockers etc.
Pregnant and lactating women.
BMI: less than 25 and greater than 35 will be excluded.
In Shodhana group Virechana Ayogya as per Ayurvedic Classics will be excluded
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce weight gain (obesity) in the patients |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To improve quality of life of obesity patients |
35 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3 |
|
Date of First Enrollment (India)
|
15/04/2021 |
| 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="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Publication on the research will be done at indexed peer reviewed journal |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Obesity
is an alternate cause of death worldwide, with increasing prevalence in adults
and children. It is one of the
most serious public health problems of the 21st century. Though
modern system of medicine has its own therapeutic modalities in tackling
obesity, they are very commonly associated with many adverse effects. Surgery
done for fat removal has so many temporary and long term complications like
Bleeding, Internal hernia, Hair loss etc. Considering this, the global
population is enthusiastically looking towards effective natural remedies. Obesity is a serious problem and an effective solution
is needed to find out. Ayurveda has
solution to this current problem Ayurveda not only treat Obesity but
also treats a person who is obese or overweight.
Thus,
Obesity is a serious problem and a serious solution is needed to find out. So
this disease is selected for research work.
|