| CTRI Number |
CTRI/2025/02/081051 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
08/02/2025 |
| 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
|
A clinical trial to study the effect of Chagaladya Ghrita in patients with Muscle Wasting Disorders. |
|
Scientific Title of Study
|
Comparative clinical study to evaluate efficacy of Chagaladya ghrita with resistance exercise in sarcopenia. |
| 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 Vikrant Londhe |
| Designation |
PG Scholar |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) |
| Address |
Bharati Vidyapeeth (Deemed to be University) College of Ayurved and Hospital Department of Kayachikitsa OPD no 04 Katraj - Dhankawadi Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
7387505181 |
| Fax |
|
| Email |
vikrant.londhe-ayurved@bvp.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhavi Mahajan |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) |
| Address |
Bharati Vidyapeeth (Deemed to be University) College of Ayurved and Hospital Department of Kayachikitsa OPD no 04 Katraj - Dhankawadi Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9860124248 |
| Fax |
|
| Email |
madhavi.mahajan@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhavi Mahajan |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) |
| Address |
Bharati Vidyapeeth (Deemed to be University) College of Ayurved and Hospital Department of Kayachikitsa OPD no 04 Katraj - Dhankawadi Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9860124248 |
| Fax |
|
| Email |
madhavi.mahajan@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth college of ayurved and hospital OPD NO 4 AND 2ND FLOOR IPD KATRAJ DHANKAWADI PUNE 411043 |
|
|
Primary Sponsor
|
| Name |
DrVikrant Londhe |
| Address |
Bharati Vidyapeeth (Deemed to be University) College of Ayurved and Hospital Department of Kayachikitsa OPD no 04 Katraj - Dhankawadi Pune India 411043 |
| Type of Sponsor |
Other [vikrant.londhe-ayurved@bvp.edu.in] |
|
|
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 |
| Drvikrant arjun londhe |
Bharati Vidyapeeth Deemed to be university college of ayurveda and hospital |
Department of kayachikitsa ,OPD no 4 ground floor , IPD 2ND Floor bharati vidyapeeth ayurved hospital
Pune
MAHARASHTRA |
8600186865
vikrant.londhe-ayurved@bvp.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M959||Acquired deformity of musculoskeletal system, unspecified. Ayurveda Condition: MAMSAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Chagaladya Ghrita, Reference: Bhaishayjya Ratnavali, Route: Oral, Dosage Form: Ghrita, Dose: 20(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: warm water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Resistance exercise | The resistance exercise given with thera bands to the person at one time and it will be given for total duration of 60 days |
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patient having age between 60 yrs to 80 yrs irrespective of gender.
SARC F scores more than 4 by 10 |
|
| ExclusionCriteria |
| Details |
Uncontrolled diabetes mellitus blood sugar levels are above recommended target ranges
including an HbA1C level above 10.0percent, BSL F more than 200MG per DL , BSL PP more than 300MG per DL
• Uncontrolled hypertension blood pressure that remains above the goal in spite of the
concurrent use of 3 antihypertensive agents of different classes. Ideally, one of the 3 agents
should be a diuretic and all agents should be prescribed at optimal dose amounts.
• Uncontrolled thyroid disease.
• History of serious cerebro cardiovascular diseases , fracture during previous year,
malignancy within 6 months .
• Arthritis, severe enough to prevent completion of the strength testing, history of joint
replacement of knees or hip. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Improvement in muscle strength . 2 Improvement in lean muscle mass.
3 Improvement in functional capacity. |
baseline, 15th, 30th, 45th, 60th day folloup |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in HS CRP level.
• Improvement in body circumference.
• Improvent in quality of life. |
baseline, 15th, 30th, 45th, 60th day folloup |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/03/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
The study will conducted after obtaining permission from institutional ethical community and will be regesistred CTRI india. As per inclusion criteria patient will be selected and screening done at OPD and IPD. Subjective and Objective parameter will be checked and noted. Whole research procedure and aim will be clearly informed to patient hence form will be signed by enrolled participant and case report form will be filled |