CTRI Number |
CTRI/2025/04/085232 [Registered on: 21/04/2025] Trial Registered Prospectively |
Last Modified On: |
21/04/2025 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Single Arm Study |
Public Title of Study
|
Ayurveda treatment for Post Menopausal Women |
Scientific Title of Study
|
Effectiveness of Ayush Osto (coded Ayurvedic formulation) in post -menopausal women with Osteopenia- A prospective single arm multi centric 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 Babita Yadav |
Designation |
Research Officer (Ay.) |
Affiliation |
Central Ayurveda Research Institute under CCRAS |
Address |
Dr Babita Yadav, 2nd floor, Dhanvantri Bhawan, Road No.66, Punjabi Bagh (West), New Delhi Flat no -1089,U.F.Appartment, Plot No-7 Sector-6,Dwarka, Delhi-110075 North DELHI 110026 India |
Phone |
9910171143 |
Fax |
|
Email |
drbabitayadav@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Babita Yadav |
Designation |
Research Officer (Ay.) |
Affiliation |
Central Ayurveda Research Institute under CCRAS |
Address |
Dr. Babita Yadav, 2nd floor, Dhanvantri Bhawan, Road No.66, Punjabi Bagh (West), New Delhi Flat no -1089,U.F.Appartment, Plot No-7 Sector-6,Dwarka, Delhi-110075 North DELHI 110026 India |
Phone |
9910171143 |
Fax |
|
Email |
drbabitayadav@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Renu Rani |
Designation |
Research Officer (Ay.) |
Affiliation |
Central Ayurveda Research Institute, CCRAS |
Address |
Dr. Renu Rani, 1st floor, IPD Block, Dhanvantri Bhawan, Road No.66, Punjabi Bagh (West), New Delhi Villa No. 56, Royal Green Homes, Beri Road, Near PDM, Bahadurgarh- Haryana-124507 North DELHI 110026 India |
Phone |
9586734447 |
Fax |
|
Email |
drrenurani1990@gmail.com |
|
Source of Monetary or Material Support
|
Central Council for Research in Ayurvedic Sciences, No.61-65, Institutional Area, Opp. D Block,
Janakpuri, New Delhi - 110058 |
|
Primary Sponsor
|
Name |
Central Council for Research in Ayurvedic Sciences |
Address |
Central Council of Research in Ayurvedic Sciences, Ministry of
Ayush, Govt. of India, Jawahar Lal Nehru Bhartiya Chikitsa Evam
Homeopathy Anusandhan Bhawan, No. 61-65, Institutional area,
Opp. D block, New Delhi- 110058 |
Type of Sponsor |
Research institution |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 2 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Kamini Dhiman |
All India Institute of Ayurveda |
Room No. 402, Deptt of SRPT, AIIA, Sarita Vihar, New Delhi-110076 South DELHI |
8920900968
kd44ayu@yahoo.co.in |
Dr Divya B |
Parul Institute of Ayurved and Research |
Dept of Panchakarma, Ishwarpura, Post Limda, Taluka Waghodia, District Vadodara-391760 Vadodara GUJARAT |
9844810958
dr.divyadeva3@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 2 |
Name of Committee |
Approval Status |
All India Institute of Ayurveda |
Approved |
Institutional Ethical Committee IEC- PIARHR |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:M859||Disorder of bone density and structure, unspecified. Ayurveda Condition: ASTHISOSHAH, |
|
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 |
50.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Female |
Details |
i. Women between 50 and 70 years with history of spontaneous amenorrhea for equal or more than 12 months.
ii. B.M.D. T score between -1.0 and -2.5 measured by DXA Scan of neck of femur or lumbar spine.
|
|
ExclusionCriteria |
Details |
1. Patients with a history of congenital disorders related to bone like Dysosteogenesis, Marfans Syndrome, Osteomalacia and Pagets disease.
2. Patients with a history of Endocrinal disorders like Thyroid and parathyroid dysfunction, Hyperprolactinemia and Cushings syndrome.
3. Patients with history of Malabsorption syndrome.
4. Patients who have undergone Organ transplantation, who are immobilized for more than 6 weeks, traumatic bone fractures in last 6 months.
5. Patients with a history of any Malignancy.
6. Known cases of uncontrolled diabetes mellitus with HbA1c more than 8 percent, uncontrolled hypertension with BP equal or more than 160 per 100 mm Hg, Renal dysfunction defined as Serum creatinine more than 1.2 mg per dl, Hepatic dysfunction defined as AST and ALT more than 2 times of the normal upper limit, cardiac dysfunction, urolithiasisis and any other condition that may jeopardize the study.
7. Patients on calcium and Vitamin D supplementation or any osteopenia treatment or hormone replacement therapy.
8. Patients who are participating in any clinical trial currently or have completed participation in any other clinical trial during the past 6 months.
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Change in bone mineral density |
At Baseline, 90th day( for every 10th patient) and 180th day assessed by DXA scan. |
|
Secondary Outcome
|
Outcome |
TimePoints |
i.Change in hematological & biochemical parameters (Liver function test & renal function tests)
ii. Assessment of the tolerability of the Ayurveda therapeutic regimen through reported incidence of adverse events during the study period.
iii. Assessment of treatment adherence through self-reported compliance log & counting of used medication containers/strips.
|
i.90th day & 180th day as compared to baseline
ii. Day 30, 60, 90,120,150,180
iii. Day 1 to Day 180
|
|
Target Sample Size
|
Total Sample Size="110" Sample Size from India="110"
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 |
Date of First Enrollment (India)
|
14/07/2025 |
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="2" 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
|
Osteopenia is a clinical term used to describe a decrease in bone mineral density (BMD) below normal reference values, yet not low enough to meet the diagnostic criteria to be considered osteoporotic . Osteopenia, as defined by the World Health Organization (WHO), is a t-score between -1 to -2.5, while values less than -2.5 are diagnostic for osteoporosis. Decreasing BMD values are reflective of an underlying disruption in the microarchitecture of bone and osteopenia, and osteoporosis is considered quantitative, not qualitative, disorders of bone mineralization. While it is estimated that heritable factors dictate up to 80% of our ability to achieve and maintain optimal bone mineralization levels, modifiable factors attributed to the rate of natural bone mass reduction into adulthood include weight-bearing exercises, nutrition status (adequate calcium and vitamin D daily intake), body mass, and hormonal milieu. Postmenopausal women are more likely to develop osteoporosis, which not only causes morbidity but also has a substantial negative influence on their quality of life. It is necessary to evaluate the quality of life of women with reduced BMD before fractures occur, to aid development of health education aiming to reduce the incidence of osteoporosis and prevent fractures. Since there is decrease of bone tissue in this disease, it can be considered as Asthi-Majjakshaya because of its core of pathogenesis: 1) degeneration of bone tissue and 2) vitiation of Vata .A few studies on the use of herbal and herbo mineral drugs for the treatment of osteopenia/osteoporosis have been conducted before. Ayush Osto is a coded Ayurvedic formulation for the management of Asthikshaya (Osteoporosis & Osteopenia undertaken for drug development by the Council through a systematic process of drug development viz. drug standardization and experimental toxicity studies [Acute toxicity in mice, repeated dose toxicity (28 days and 90 days) in wistar rats.] The test drug was found safe at different dose levels. Keeping in view of the above scenario, this multicentric study has been designed to evaluate the effect of Ayush Osto in improving bone mineral density. |