| CTRI Number |
CTRI/2023/09/057461 [Registered on: 12/09/2023] Trial Registered Prospectively |
| Last Modified On: |
24/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the Efficacy of osto-guard granules asthishrunkhala with milk in low bone mineral density levels in post menopausal women |
|
Scientific Title of Study
|
Open randomized controlled clinical trail to evaluate the efficacy of osto-guard granules asthishrunkhala with milk in low bone mineral density levels in post menopausal 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 Rutuja Raghunath More |
| Designation |
PG scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduateand Research Center Ashta |
| Address |
OPD no 6 Strirog And Prasuti Tantra OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
7030099653 |
| Fax |
|
| Email |
7266morerutuja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tinku Ganesh Khalache |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduateand Research Center Ashta |
| Address |
3rd Floor Department Of Strirog And Prasuti Tantra Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate Research center Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9423041730 |
| Fax |
|
| Email |
tinkuganeshkhalache@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tinku Ganesh Khalache |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduateand Research Center Ashta |
| Address |
3rd Floor Department Of Strirog And Prasuti Tantra Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate Research center Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9423041730 |
| Fax |
|
| Email |
tinkuganeshkhalache@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and ResearchCenter Ashta |
|
|
Primary Sponsor
|
| Name |
Dr Rutuja Raghunath More |
| Address |
OPD no 6 Strirog And Prasuti Tantra OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangli |
| 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 Rutuja Raghunath More |
Hon Shri Annasaheb Dange Ayurved Medical College And Dhanvantari Ayurved Hospital Ashta |
OPD no 6 Strirog And Prasuti Tantra OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA |
7030099653
7266morerutuja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E289||Ovarian dysfunction, unspecified. Ayurveda Condition: ARTAVAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Asthishrunkhala, Reference: Kaiyadev Nighantu, Route: Oral, Dosage Form: Khanda /Granules, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: milk), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Tab Calcium | orally given tablet OD for 60 days with Normal Water |
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1 Cases having onset of Menopause within 10 yrs with Bone Mineral Density below minus 1 SD
2 Patients of any occupation religion and socio economic conditions |
|
| ExclusionCriteria |
| Details |
1 Patients diagnosed with osteoporosis BMD less than -2.5 SD
2 Premature ovarian failure Loss of normal functions of ovaries before the age of 40 years
3 Surgical menopause that is Hysterectomy
4 Endocrine disorders like Thyroid disease
5 Pagets disease
6 Malignancy
7 Postmenopausal bleeding |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of osto guard granules asthishrunkhala with milk in low bone mineral density that is bmd levels in postmenopausal women |
8 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the effect of osto guard granules with milk on serum calcium levels |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
18/09/2023 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Menopause is a estrogen deficient phase due to reduced ovarian function which causes low bone mineral density
Current study is randomized controlled clinical trial to check the effectiveness of Osto-guard Granules ie Asthishrunkhala in the management of low bone mineral density in postmenopausal women
Study consist of two groups A and B
Group A Osto-Guard Granules 5gms with milk twice a day after meal
Group B Tab.Calcium 500mg with water once a day in morning Both for 60 days |