| CTRI Number |
CTRI/2025/06/088711 [Registered on: 12/06/2025] Trial Registered Prospectively |
| Last Modified On: |
01/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effect of udavartana and trayushanadi lauha in the management of sthaulya(obesity) |
|
Scientific Title of Study
|
A comparative clinical study of the efficacy of udavartana and trayushanadi lauha as medohara in the management of sthaulya |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mandeep verma |
| Designation |
Pg scholar |
| Affiliation |
Desh bhagat ayurvedic college & hospital |
| Address |
Deptt of kayachakitsa desh bhagat ayurvedic college mandi gobindgarh punjab
Desh bhagat ayurvedic college mandi gobindgarh
Fatehgarh Sahib
PUNJAB
147301
India |
| Phone |
8146383786 |
| Fax |
|
| Email |
dr.manuverma@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satya deo pandey |
| Designation |
Director clinical research |
| Affiliation |
Desh bhagat ayurvedic college |
| Address |
Deptt of kayachakitsa desh bhagat ayurvedic college mandi gobindgarh
Fatehgarh Sahib
PUNJAB
147301
India |
| Phone |
9872583155 |
| Fax |
|
| Email |
Sdkayachikitsa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mandeep verma |
| Designation |
Pg scholar |
| Affiliation |
Desh bhagat ayurvedic college |
| Address |
Desh bhagat ayurvedic college mandi gobindgarh
Fatehgarh Sahib
PUNJAB
147301
India |
| Phone |
8146383786 |
| Fax |
|
| Email |
dr.manuverma@yahoo.com |
|
|
Source of Monetary or Material Support
|
| department of kayachikitsa, desh bhagat ayurvedic college and hospital mandi gobindgarh distt fatehgarh sahib punjab 147301 |
|
|
Primary Sponsor
|
| Name |
Department of kayachikitsa Desh bhagat ayurvedic college and hospital |
| Address |
Desh bhagat ayurvedic college mandi gobindgarh distt fatehgarh sahib punjab india 147301 |
| 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 Mandeep verma |
Desh bhagat ayurvedic college and hospital |
opd no 24 deptt of kayachikitsa
Fatehgarh Sahib
PUNJAB |
8146383786
DR.MANUVERMA@YAHOO.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E663||Overweight. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: trayushnadi lauha, Reference: yogaratnakara, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -madhuodaka), Additional Information: - | | 2 | Comparator Arm | Procedure | - | udvartanam, उद्वर्तनम् | (Procedure Reference: yogaratnakar, Procedure details: one time a day)
(1) Medicine Name: trayushanadi lauha, Reference: yogaratnakara, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
BMI more than 25 |
|
| ExclusionCriteria |
| Details |
below age of 15 years and above 60 years.patients with diabetes renal failure hepatic involvment hypothyroidiem hypertension |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| conclusion will be made on the basis of observation which will be done on subjective and objective parameters. |
conclusion will be made on the basis of observation which will be done on subjective and objective parameters.
and during follow ups on
15th day
30th day
60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/06/2025 |
| 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="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
in this trail we will evaluate the efficiency of drug called trayushnadi lauha and a procedure called udvartana in panchkarma in the people affected with obesity. conclusions will be made on the basis of observations which will be done on subjective and objective parameters and will be analysed statistically. |