| CTRI Number |
CTRI/2020/09/027793 [Registered on: 14/09/2020] Trial Registered Prospectively |
| Last Modified On: |
11/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study of Varasanadi Kashaya in Obesity |
|
Scientific Title of Study
|
Randomized Controlled Clinical Trial to Study The Efficacy of Varasanadi Kashaya in Sthaulya With Special reference to Obesity |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sonal Vishnurao Poharkar |
| Designation |
PG Scholar |
| Affiliation |
Ayurved seva sangh ayurved mahavidyalaya Nashik |
| Address |
OPD no 13 kayachikitsa Department
Nashik
MAHARASHTRA
422003
India |
| Phone |
9356218606 |
| Fax |
|
| Email |
sonalpoharkar0122@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Rajan Balwant Kulkarni |
| Designation |
Professor and Guide |
| Affiliation |
Ayurved Mahavidyalaya Nashik |
| Address |
OPD no 13 kayachikitsa Department
Nashik
MAHARASHTRA
422003
India |
| Phone |
9823350440 |
| Fax |
|
| Email |
vaidyarajankulkarni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Rajan Balwant Kulkarni |
| Designation |
Professor and Guide |
| Affiliation |
Ayurved Mahavidyalaya Nashik |
| Address |
OPD no 13 kayachikitsa Department
Nashik
MAHARASHTRA
422003
India |
| Phone |
9823350440 |
| Fax |
|
| Email |
vaidyarajankulkarni@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.Sonal Vishnurao Poharkar Ayurved Seva Sanghs Ayurved Mahavidyalaya Nashik Ganeshwadi Panchvati Nashik 422003 |
|
|
Primary Sponsor
|
| Name |
Ayurved Mahavidyalaya Nashik |
| Address |
Ganeshwadi Panchavati Nashik |
| Type of Sponsor |
Other [Govt aided Institution ] |
|
|
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 Sonal Vishnurao Poharkar |
Arogyashala Rugnalaya |
OPD no 13 kayachikitsa Department
Nashik
MAHARASHTRA |
9356218606
sonalpoharkar0122@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
obese people |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Asansar kashaya |
40 ml twice a day before meal for 30 days |
| Intervention |
Varasanadi kashaya |
40 ml twice a day before meal for 30 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
WHR (waist hip circumference ratio) >0.9 in males and >0.8 in females
Patient of sthaulya with BMI range from 25 to 35
Patient willing for trial and giving written consent. |
|
| ExclusionCriteria |
| Details |
Patients having BMI less than 25
Patients having complications uncontrolled diabetes,uncontrolled hypothyroidism,uncontrolled hypertension, cardiovascular diseases etc
Patients having poorly controlled blood pressure >160/100 mmHg
Patients on prolonged medication (>6weeks) with corticosteroids, or any other drugs that may have an influence on the outcome of the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in BMI
Reduction in waist and hip circumference |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| joint pain reduced |
30 days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
16/09/2020 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
obesity and overweight are increasing problems in present era. in process of modernization and rapid urbanization human beings are more prone to various disorder sthaukya is one of them. a number of herbal medicine described in various ancient text of ayurveda for treating them amoung this sahasatrayog kalpa varasanadi kashaya with ingredient like triphala , asana , agni , ayapatra , nisha have medohar action are included in it.
|