| CTRI Number |
CTRI/2025/03/083009 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
02/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study held to see the efficacy of an ayurvedic formulation in the management of Osteoporosis. |
|
Scientific Title of Study
|
Evaluation of the efficacy of an Ayurvedic Formulation in Asthikshaya (Osteoporosis) - A Clinical study |
| 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 Bhumika Bhagvati Jain |
| Designation |
MD Scholar Kayachikitsa |
| Affiliation |
Dr.D.Y.Patil college of Ayurved and research center |
| Address |
Dr.D.Y.Patil college of Ayurved and research center, Sant Tukaram nagar, Pimpri Pune 411018 Maharashtra
Pune
MAHARASHTRA
411018
India |
| Phone |
9987158343 |
| Fax |
|
| Email |
bhumii2607@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Digambar Dipankar |
| Designation |
MD Kayachikitsa |
| Affiliation |
Dr.D.Y.Patil college of Ayurved and research center |
| Address |
Dr.D.Y.Patil college of Ayurved and research center, Sant Tukaram nagar, Pimpri Pune 411018 Maharashtra.
Pune
MAHARASHTRA
411018
India |
| Phone |
9822279321 |
| Fax |
|
| Email |
drdgdipankar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhumika Bhagvati Jain |
| Designation |
MD Scholar Kayachikitsa |
| Affiliation |
Dr.D.Y.Patil college of Ayurved and research center |
| Address |
Dr.D.Y.Patil college of Ayurved and research center, Sant Tukaram nagar, Pimpri Pune 411018 Maharashtra
Pune
MAHARASHTRA
411018
India |
| Phone |
9987158343 |
| Fax |
|
| Email |
bhumii2607@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.D.Y.Patil college of Ayurved and research center Sant tukaram Nagar Pimpri Pune 411018
Maharashtra |
|
|
Primary Sponsor
|
| Name |
Dr Bhumika Bhagvati Jain |
| Address |
Dr.D.Y.Patil college of Ayurved and research center Sant tukaram
Nagar Pimpri Pune 411018 |
| Type of Sponsor |
Other [[Self]] |
|
|
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 Bhumika Bhagvati Jain |
Dr.D.Y.Patil college of Ayurved and research center Pimpri Pune |
OPD no -5 Kayachikitsa
Department
Dr.D.Y.Patil college of
Ayurved and research
center Pimpri Pune
411018 Maharashtra
Pune
MAHARASHTRA |
9987158343
bhumii2607@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 | Drug | Classical | | (1) Medicine Name: Ayurvedic formulation , Reference: Bhavprakash nighantu, Dhanvantari Nighantu , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Goghrut ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having two or more clinical features of Asthikshaya like pain in bones, hair fall, skin and nail dryness, fatigue, joint loosening.
Patients with BMD (t-score) greater than 2.4
Patients with age group of 30 to 60 years. |
|
| ExclusionCriteria |
| Details |
• Patients with history of any fracture or is operated within 12 months.
• Pregnant and lactating women.
• Patients taking calcium supplements.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • The symptoms of Asthikshaya such as pain in bones, hair fall are expected to be reduced. |
28 days study with 2 follow ups (0,14,28) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Improvement in t-score of Bone Mineral Density.
• Improvement in Serum Calcium levels in blood.
|
28 days study with 2 follow ups (0,14,28) |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
02/04/2025 |
| Date of Study Completion (India) |
30/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 aim is to study the effectiveness of an Ayurvedic Formulation in management of Asthikshaya (Osteoporosis) the study will be conducted with 45 patients showing signs and symptoms of Asthikshaya, they will be administered with Ayurvedic formulation 2 tablets twice a day with goghrut for the duration, conclusion will be drawn on the basis of proper statistical methods. |