| CTRI Number |
CTRI/2022/10/046678 [Registered on: 20/10/2022] Trial Registered Prospectively |
| Last Modified On: |
13/10/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To assess the effect of Vidaryaadi ghruta and resistance exercise on age related muscle weakness |
|
Scientific Title of Study
|
To assess the efect of VDG and resistance exercise on muscle health in sarcopenia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Madhavi Mahajan |
| Designation |
Asso. Professor |
| Affiliation |
Bharati vidyapeeth college of Ayurveda and hospital |
| Address |
Department of Kaychikitsa Bharat vidyapeeth college of Ayurveda and hospital pune
Department of Kaychikitsa Bharati vidyapeeth college of Ayurveda and hospital, Dhankawdi pune
Pune
MAHARASHTRA
411043
India |
| Phone |
|
| Fax |
|
| Email |
drmadhavim@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhavi Mahajan |
| Designation |
Asso. Professor |
| Affiliation |
Bharati vidyapeeth college of Ayurveda and hospital |
| Address |
Department of Kaychikitsa Bharat vidyapeeth college of Ayurveda and hospital pune
Department of Kaychikotsa Bharati vidyapeeth college of Ayurveda and hospital, Dhankawdi pune
Pune
MAHARASHTRA
411043
India |
| Phone |
|
| Fax |
|
| Email |
drmadhavim@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhavi Mahajan |
| Designation |
Asso. Professor |
| Affiliation |
Bharati vidyapeeth college of Ayurveda and hospital |
| Address |
Department of Kaychikitsa Bharati vidyapeeth college of Ayurveda and hospital pune
Department of Kaychikitsa Bharati vidyapeeth college of Ayurveda and hospital, Dhankawdi pune
Pune
MAHARASHTRA
411043
India |
| Phone |
|
| Fax |
|
| Email |
drmadhavim@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Bharati vidyapeeth deemed to be university college of Ayurveda and hospital |
| Address |
Bharati vidyapeeth deemed to be university college of Ayurveda and hospital dhankawdi pine 43 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Madhavi Mahajan |
Bharat vidyapeeth college of Ayurveda and hospital |
Bharat vidyapeeth Deemed to be university college of Ayurveda and hospital dhankawdi pune
Pune
MAHARASHTRA |
9860124248
drmadhavim@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BVDUCOA Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M628||Other specified disorders of muscle. Ayurveda Condition: MAMSAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vidaryadi ghrut, Reference: Ashtang Hruday Su. Adhyay 15, Route: Oral, Dosage Form: Ghrita, Dose: 05(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: - | | 2 | Intervention Arm | Lifestyle | - | - | Dinacarya: Resistance Exrecise, Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
SARC -F scores <4/10
Willing and able to comply with clinic visits and study related procedures |
|
| ExclusionCriteria |
| Details |
Uncontrolled DM, HTN and thyroid disease, H/O- CVA malignancy within 6 months, use of internal steroids, H/O joint replacement of knee or hip, arthritis |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in muscle strength, in lean muscle mass,in functional capacity |
Improvement in muscle strength, in lean muscle mass,in functional capacity in 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in HS, CRP level in body circumference in quality of life, decrease in total body fat |
90 days |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
31/10/2022 |
| 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 Yet Recruiting |
| 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
|
Ayurveda highlighted degenerative diseases under the concept like dhatushaithilya and dhatukshay .Mamsakshay is one of the condition which needs a specific target of therapeutic intervention to check slow down the process of dhatukshay. We will assess the efficacy of vidariadi ghruta and resistance exercise on muscle health in Sarcopenia |