| CTRI Number |
CTRI/2022/12/048151 [Registered on: 15/12/2022] Trial Registered Prospectively |
| Last Modified On: |
13/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Natural remedies on obesity |
|
Scientific Title of Study
|
"RANDOMIZED OPEN CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF ERAND KSHAR PRAYOGA IN MANAGEMENT OF STHAULYA" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rameshwari Ramesh Khandare |
| Designation |
PG scholar |
| Affiliation |
yashwant ayurvedic medical collage and research center kodoli |
| Address |
kayachikitsa department Yashwant Ayurvedic Medical College and
Research Center Kodoli,Tal Panhala, Dist Kolhapur,Room no.17.
MAHARASHTRA
416114
India
kayachikitsa department Yashwant Ayurvedic Medical College and
Research Center Kodoli,Tal Panhala, Dist Kolhapur,Room no.17.
MAHARASHTRA
416114
India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7350122088 |
| Fax |
|
| Email |
rameshwari.gandhale@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dipali Swami |
| Designation |
MD Kayachikitsa |
| Affiliation |
yashwant ayurvedic medical collage and research center kodoli |
| Address |
kayachikitsa department Yashwant Ayurvedic Medical College and
Research Center Kodoli,Tal Panhala, Dist Kolhapur,Room no.17.
MAHARASHTRA
416114
India
kayachikitsa department Yashwant Ayurvedic Medical College and
Research Center Kodoli,Tal Panhala, Dist Kolhapur,Room no.17.
MAHARASHTRA
416114
India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9960003947 |
| Fax |
|
| Email |
drdipaliswami06@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rameshwari Ramesh khanadare |
| Designation |
PG scholar |
| Affiliation |
yashwant ayurvedic medical collage and research center kodoli |
| Address |
kayachikitsa department Yashwant Ayurvedic Medical College and
Research Center Kodoli,Tal Panhala, Dist Kolhapur,Room no.17.
MAHARASHTRA
416114
India
kayachikitsa department Yashwant Ayurvedic Medical College and
Research Center Kodoli,Tal Panhala, Dist Kolhapur,Room no.17.
MAHARASHTRA
416114
India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7350122088 |
| Fax |
|
| Email |
rameshwari.gandhale@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant ayurvrdic college post graduate training and research center kodoli,Tal-pahnala,Dist-kolhapur. |
|
|
Primary Sponsor
|
| Name |
Yashwant ayurvedic medical college and research center kodoli |
| Address |
Yashwant Ayurvedic Medical College and
Research Center Kodoli,Tal Panhala, Dist Kolhapur,Room no.17.
MAHARASHTRA
416114
India |
| Type of Sponsor |
Private medical college |
|
|
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 Rameshwari Ramesh Khandare |
Yashwant ayurvedic medical college and research center kodoli |
Yashwant Ayurvedic Medical College and
Research Center Kodoli,Tal Panhala, Dist Kolhapur,Department-Kayachikitsa, Room no-17
MAHARASHTRA
416114
India
Kolhapur
MAHARASHTRA |
7350122088
rameshwari.gandhale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committe ,yashwant ayurvedic college,PGT and RC kodoli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R688||Other general symptoms and signs. Ayurveda Condition: other specified obese, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Erand Kshar, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Kshara , Dose: 1(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Koshna jal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) patient will be selected on the basis of B.M.I (Body mass Index) 25 to 35
2) Overweight and obesity
3) Hereditary obesity
|
|
| ExclusionCriteria |
| Details |
1)K/HO sever Hypertension
2)pregnant women not be selected
3)below 18 years age
4)Hyper acidity
5)any other systematic disease like cardiac ,renal, liver disorder ,bleeding disorder
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Atikshuda
Atipipasa
Daurbalyata
Ayasen shwas |
4 Weeks to 8 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| weight loss |
90 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
20/12/2022 |
| 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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
sthaulya is chronic disease and not only it affects the body and health but also affects day to day activities of human being . so the patients is hampered physically as well as mentally. if disease is progresses deformity can occur.
The neglect leads to various disorder in their health , the occurrence of sthaulya on large scale is one of the outcome of this diseases .
as the allopathic drug have many side effect so erand kshar prayoga is subjected to clinical trail in patients suffering from sthaulya disease.
|