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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  
Name  Address 
NIL   
 
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  
Status 
Not Applicable 
 
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  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther 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.

 
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