| CTRI Number |
CTRI/2025/07/090656 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To observe the effect of Ayurvedic medicine for the treatment of Osteoporosis in the Post Menopausal Women. |
|
Scientific Title of Study
|
An exploratory study to assess the effect of Ayush Osto on the bone turnover markers among post-menopausal osteoporotic women. |
| 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 Rinku Tomar |
| Designation |
Research Officer(Ayu.) |
| Affiliation |
Central Council for Research in Ayurvedic Sciences |
| Address |
Central Ayurveda Research Institute, Patiala, Room No. 211, Clinical and Research
Central Ayurveda Research Institute, Patiala, Room No. 211, Clinical and Research
Patiala
PUNJAB
147001
India |
| Phone |
9888685874 |
| Fax |
|
| Email |
drrinkutomer1977@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rinku Tomar |
| Designation |
Research Officer(Ayu.) |
| Affiliation |
Central Council for Research in Ayurvedic Sciences |
| Address |
Central Ayurveda Research Institute, Patiala, Room No. 211, Clinical and Research
Central Ayurveda Research Institute, Patiala, Room No. 211, Clinical and Research
Patiala
PUNJAB
147001
India |
| Phone |
9888685874 |
| Fax |
|
| Email |
drrinkutomer1977@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rinku Tomar |
| Designation |
Research Officer(Ayu.) |
| Affiliation |
Central Council for Research in Ayurvedic Sciences |
| Address |
Central Ayurveda Research Institute, Patiala, Room No. 211, Clinical and Research
Central Ayurveda Research Institute, Patiala, Room No. 211, Clinical and Research
Patiala
PUNJAB
147001
India |
| Phone |
9888685874 |
| Fax |
|
| Email |
drrinkutomer1977@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurvedic Sciences, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homeopathy Anusandhan Bhawan 61 65 Institutional Area Opposite D Block Janakpuri New Delhi 110058 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Ayurvedic Sciences |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homeopathy Anusandhan Bhawan 61 65 Institutional Area Opposite D Block Janakpuri New Delhi 110058 |
| Type of Sponsor |
Research institution |
|
|
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 Rinku Tomar RO Ayurveda |
Central Ayurveda Research Institute |
Central Ayurveda Research Institute,Moti Bagh Road, Patiala, Room No. 211, Clinical and Research
Patiala
PUNJAB |
09888685874
drrinkutomer1977@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Central Ayurveda Research Institute Moti Bagh Road Patiala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M00-M99||Diseases of the musculoskeletal system and connective tissue. Ayurveda Condition: ASTHIKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Ayush Osto, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 180 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Women age less than 70 years with history of spontaneous amenorrhea for equal or more than 12 months.
B M D T score at or below -2.5 measured by DXA Scan of Hip region proximal femur.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Bone Formation [SerumProcollagen Type I N-terminal Propeptide, Alkaline phosphatase (Total and Bone specific), Osteocalcin] and Bone Resorption (Serum CTX) Markers level at the end of treatment i.e. on 180th day as compared to baseline. |
Change in Bone Formation [SerumProcollagen Type I N-terminal Propeptide, Alkaline phosphatase (Total and Bone specific), Osteocalcin] and Bone Resorption (Serum CTX) Markers level at the end of treatment i.e. on 180th day as compared to baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in Quality of Life score by using Qualeffo-41 questionnaire at the end of treatment as compared to baseline.
Incidence of fractures associated with the osteoporosis during the study.
Change in hematological & biochemical parameters (Liver function test & Renal function tests) during (at 60th day) & end of the study period (at 180th day).
Incidence of treatment emergent adverse events during study. |
Baseline & at end of the treatment i.e. on 180th day. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/08/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Osteoporosis is a disease that is characterized by a low bone mass and a micro architectural deterioration of the bone tissue, which leads to enhanced bone fragility and a consequent increase in the fractures. The National Osteoporosis Foundation (NOF) estimates there are 9.1 million women with osteoporosis and an additional 26 million with low bone mass. This far exceeds the estimated number of men with osteoporosis, 2.8 million, and with low bone mass, 14.4 million. [1] Worldwide, the lifetime risk for women to have an osteoporotic fracture is 30-40%. [2] One out of two Indian women above the age of 50 years and one out of five Indian men above the age of 65 years are at risk of osteoporosis.[3,4] In India, osteoporotic fractures are a major cause of morbidity and mortality in the elderly, as in the West. Asthikshaya is a condition in which there is a decrease in the Asthidhatu (Bone tissue), leading to many undesirable effects. It can be compared with osteoporosis, in which there is a decrease in Bone Mineral Density (BMD), leading to an increased risk of fractures. Ayush Osto is an Ayurvedic formulation for the management of Asthikshaya (Osteoporosis & Osteopenia undertaken for drug development by the Council through a systematic process of drug development. | Keeping in view the above scenario, a study has been designed which is intended to evaluate the effect of Ayush Osto on the bone turnover markers (bone formative-Serum PINP, Alkaline phosphatase (Total and Bone specific), Osteocalcin and bone resorptive-serum CTX) among postmenopausal osteoporosis (Asthikshaya) women. | |