| CTRI Number |
CTRI/2025/07/091717 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study on the effect of Matra Basti and Asthishrinkhala Ghan Vati in Osteoporosis in Post-menopausal Women |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Efficacy Of Matra Basti With Asthisandhanak Tail (Kalpit Yoga) And Asthishrinkhala Ghan Vati In The Management Of Asthikshaya (Post Menopausal Osteoporosis) |
| 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 Asha Meena |
| Designation |
PG Scholar |
| Affiliation |
Post Graduate Institute of Ayurved |
| Address |
PG Department of Panchakarma Post Graduate Institute of Ayurved
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Campus
Kadvad Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9530340053 |
| Fax |
|
| Email |
ashameena744@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gyan Prakash Sharma |
| Designation |
Associate Professor Head Of Department Panchakarma |
| Affiliation |
Post Graduate Institute of Ayurved |
| Address |
Room No 11 PG Department of Panchakarma Post Graduate
Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved
University Campus Kadvad Jodhpur
Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9829798701 |
| Fax |
|
| Email |
atreyagyan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gyan Prakash Sharma |
| Designation |
Associate Professor Head Of Department Panchakarma |
| Affiliation |
Post Graduate Institute of Ayurved |
| Address |
Room No 11 PG Department of Panchakarma Post Graduate
Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved
University Campus Kadvad Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9829798701 |
| Fax |
|
| Email |
atreyagyan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University
Jodhpur 342037 Rajasthan INDIA |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurved DSRRAU Jodhpur |
| Address |
PG Department of Panchakarma Post Graduate Institute of Ayurved
DSRRAU Jodhpur 342037 Rajasthan INDIA |
| Type of Sponsor |
Government 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 Asha Meena |
Post Graduate Institute of Ayurveda |
Room Number 11 PG Department of
Panchakarma Post
Graduate Institute of
Ayurved Dr Sarvepalli
Radhakrishnan
Rajasthan Ayurved
University Campus
Karwad Jodhpur Rajasthan India 342037
Jodhpur
Jodhpur
RAJASTHAN |
9530340053
ashameena744@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Post Graduate Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M810||Age-related osteoporosis without current pathological fracture. Ayurveda Condition: ASTHIKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | mAtrAbastiH, मात्राबस्तिः | (Procedure Reference: Charak Samhita Sutra Sthan Chapter 28 Sloka Number 27, Procedure details: Matra Basti With Asthisandhanak Tail will be administered rectally in a dose of 60 ml once daily for 16 days after meals. Before administration the patient will undergo local Abhyanga with Murchita Tila Tail & Swedana over the kati vakshana and pakvashaya region.The basti oil will be given lukewarm and the patients will lie in the left lateral position during administration.The patient will be advised to retain the basti for as long as possible ideally around 9 hours with appropriate dietary and lifestyle instruction as per classical ayurvedic texts )
(1) Medicine Name: (1) Asthisandhanak Tail , Reference: Kalpit Yoga, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 16 Days(2) Medicine Name: (2) Asthishrinkhala Ghana Vati, Reference: Madanpaal Nighantu, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1000(mg), Frequency: bd, Duration: 16 Days | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Asthishrinkhala Ghan Vati, Reference: Madanpaal Nighantu , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 16 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Female patients aged between 45 and 65 years who have Bone Mineral Density T score less than minus one and present with clinical features of osteoporosis asthikshaya or asthi majjagata vata will be included in the study |
|
| ExclusionCriteria |
| Details |
Patients aged below 45 years or above 65 years and patients suffering from rheumatoid arthritis gouty arthritis or other longstanding systemic disorders will be excluded from the study Patients with diabetes mellitus uncontrolled hypertension thyrotoxicosis hyperparathyroidism Addisons disease Pagets disease Cushings syndrome tuberculosis of bone osteomalacia chronic renal disease hepatic failure or cardiac failure will also be excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in subjective and objective parameters of asthikshaya including bone mineral density after sixteen days of treatment |
16 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in quality of life and observation of any additional therapeutic effects or adverse effects during and after treatment |
16 days |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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="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
|
This clinical study is designed to evaluate the efficacy of Matra Basti with Asthisandhanak Taila and Asthishrinkhala Ghan Vati in the management of Asthikshaya, specifically postmenopausal osteoporosis. Osteoporosis is a common degenerative condition in postmenopausal women characterized by decreased bone mass and increased risk of fractures. The study is an open-label, prospective, two-arm, interventional trial conducted on 60 female patients aged between 45 and 65 years having BMD T-score less than minus one and symptoms of Asthikshaya.
Group A will receive Matra Basti with Asthisandhanak Taila 60 ml per day for 16 days. Group B will receive Asthishrinkhala Ghan Vati, 2 tablets of 500 mg twice daily for 16 days. The primary objective is to assess clinical improvement based on subjective and objective parameters, including BMD. Secondary outcome includes improvement in overall quality of life. Patients will be selected from the OPD and IPD of PG Department of Panchakarma, DSRRAU, Jodhpur. Ethical clearance will be obtained, and informed consent will be taken from each participant.
The study aims to explore the comparative efficacy of Ayurvedic basti therapy and oral herbal formulation in strengthening asthi dhatu and preventing osteoporotic complications in postmenopausal women. |