| CTRI Number |
CTRI/2023/10/058244 [Registered on: 04/10/2023] Trial Registered Prospectively |
| Last Modified On: |
03/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two drugs Medohar Guggulu and Weight Go in patients with obesity. |
|
Scientific Title of Study
|
Comparative Clinical Evaluation of the Efficacy of Medohar Guggulu and Weight Go in Sthaulya Roga (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 |
Dr Vandana |
| Designation |
Pg scholar |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar Uttarakhand India. |
| Address |
Department of kayachikitsa, OPD NO.13/14, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar Uttarakhand India.
Department of kayachikitsa, OPD NO.13/14, Patanjali ayurveda hospital Haridwar Uttarakhand India.
Hardwar
UTTARANCHAL
249405
India |
| Phone |
6284570940 |
| Fax |
|
| Email |
vandana35112@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr C B Dhanraj |
| Designation |
Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar Uttarakhand India. |
| Address |
Department of kayachikitsa, OPD NO.13/14, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar Uttarakhand India.
Department of kayachikitsa, OPD NO. 13/14, Patanjali Ayurveda Hospital, Haridwar Uttarakhand India.
Hardwar
UTTARANCHAL
249405
India |
| Phone |
917396174582 |
| Fax |
|
| Email |
drcbdhanraj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr C B Dhanraj |
| Designation |
Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar Uttarakhand India. |
| Address |
Department of kayachikitsa, OPD NO.13/14, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar Uttarakhand India.
Department of kayachikitsa, OPD NO. 13/14, Patanjali Ayurveda Hospital, Haridwar Uttarakhand India.
Hardwar
UTTARANCHAL
249405
India |
| Phone |
917396174582 |
| Fax |
|
| Email |
drcbdhanraj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
|
|
Primary Sponsor
|
| Name |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan ,Haridwar-249405 Uttarakhand
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 Vandana |
Patanjali Ayurveda Hospital |
Department of Kayachikitsa , OPD NO. 13/14, Patanjali Ayurveda hospital, Haridwar-249405 Uttarakhand India
Hardwar
UTTARANCHAL |
6284570940
vandana35112@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Medohar Guggulu, Reference: Rastantrasaar and Siddhaprayog Sangraha khand -2 chapter -30 Medoroga Page no-190 , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Weight Go, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1280(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria
Patients between the age group of 18-60 years will be selected.
Patients having classical sign and symptoms of Sthaulya.
Patients of either gender will be selected.
Patients between BMI of 25-40 kg/m2 will be selected.
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria
Drug induced obesity.
Patients having serious diseases such as hepatic disease, cardiac disease, renal disease, pulmonary disease, history of thyroid , uncontrolled hypertension and Diabetes mellitus, other endocrine disorders will be excluded.
Other systemic diseases which intervenes with the course of treatment.
Patients having BMI > 40kg/m2 will be excluded.
Pregnant females and lactating women will be excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective parameters-Grading will be done considering sign and symptoms of sthaulya-
1. Sphig chalatva (Pendlous movement of buttocks)
2. Udara chalatva (Pendulous movement of belly)
3. Stana chalatva (Pendulous movement of breast)
4. Swasa kasta (Breathlessness)
5. Janusandhishoola (Pain in both knee joints)
6. Atinidra (Excessive sleep)
7. Kshudaatimatram (Increased hunger)
8. Pipasaatiyogam (Excessive thirst)
9. Swedabadha (Excessive sweating)
10. Daurgandhya (Foul smell from body)
11. Daurbalya (Weakness)
Objective parameter-
1. Body weight
2. Body Mass Index
3. Waist-Hip ratio
4. Measurement of circumference: Chest,abdomen,hip
is assessed |
0day 30days 60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Objective parameter-
1. Body weight
2. Body Mass Index
3. Waist-Hip ratio
4. Measurement of circumference: Chest,abdomen,hip
is assessed |
0th day 30th day 60th day |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
14/10/2023 |
| 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 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
|
This
study is a open label, double arm comparative study, comparing the efficacy of
Medohar Guggulu each 500mg 2 tab twice daily after meal and Weight go each 640
mg 2 tab daily after meal in 40 patients with sthaulya roga
that will be conducted in Opd no. 13/14 in Patanjali ayurvedic hospital,
Haridwar. Assessment will be done on the basis of subjective and objective parameter. Route of administration- Oral route Follow up- Follow up will be done to observe effects of treatment or any adverse effect on the patient. 1st follow up- 1 month after commencement of treatment 2nd follow up- 1 month after the 1st follow up. |