| CTRI Number |
CTRI/2024/09/073536 [Registered on: 06/09/2024] Trial Registered Prospectively |
| Last Modified On: |
30/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Clinically assess the effect of Babula Phala in Asthikshya (Osteoporosis) |
|
Scientific Title of Study
|
Pharmacotherapeutic study to assess the efficacy of Babula Phala ( Fruit of Acacia arabica Willd.) in Asthikshya (osteoporosis) |
| 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 Shraddhaben Hathishangbhai Jadav |
| Designation |
2nd year M.D.Scholar |
| Affiliation |
Government Ayurveda Collage, Vadodara |
| Address |
Post graduate department of Dravyaguna Government Ayurveda College, Ajwa road,Dhanvantari marg, Panigate
Vadodara
Gujarat
390019
India
Vadodara
GUJARAT
390019
India |
| Phone |
9687829846 |
| Fax |
|
| Email |
shraddhabajadav15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Dharmendra P Jani |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurveda Collage, Vadodara |
| Address |
Post graduate department of Dravyaguna Government Ayurveda College, Ajwa road,Dhanvantari marg, Panigate
Vadodara
Gujarat
390019
India
Vadodara
GUJARAT
390019
India |
| Phone |
9898424365 |
| Fax |
|
| Email |
drjani13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrNileshKumar M Patel |
| Designation |
Lecturer (Class- II) |
| Affiliation |
Government Ayurveda Collage, Vadodara |
| Address |
Post graduate department of Dravyaguna Government Ayurveda College, Ajwa road,Dhanvantari marg, Panigate
Vadodara
Gujarat
390019
India
Vadodara
GUJARAT
390019
India |
| Phone |
9974319017 |
| Fax |
|
| Email |
dr.nilesh.sukhadiya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurved College and Hospital,Ajwa road, Dhanvantari marg, Panigate,
Vadodara-390019 |
|
|
Primary Sponsor
|
| Name |
Government Ayurved Hospital Vadodara |
| Address |
Government Ayurved Hospital, Ajwa road,Dhanvantari Marg, panigate, Vadodara-390019 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shraddha Jadav |
Government Ayurveda Hospital, Vadodara |
OPD and IPD, Dravyaguna Department Vadodara Gujarat Vadodara Gujarat
Vadodara
GUJARAT |
9687829846
shraddhabajadav15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE government Ayurveda College and Hospital Vadodara |
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: ASTHIKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Babula Phala, Reference: Bhavaprakasha Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: Ushnodaka), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age group between 40 to 60 years
Gender all
Patients having 3 or more classical signs & symptoms of Asthikshaya (osteoporosis) as mentioned in diagnostic criteria.
BMD (t-score) is less than -1 |
|
| ExclusionCriteria |
| Details |
Age less than 40yrs and more than 60yrs.
Pregnant women and lactating mother.
Patients associated with Autoimmune, metabolic and lifestyle diseases like RA, OA, Skeletal TB, HTN, DM, Hypothyroidism etc.
BMD (t-score) is equal or more than -1 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Asthishula (pain in bone)
Sandhi Shaithilya (looseness or weakness of joints)
|
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Asthi Sandhi Baddhata (stiffness in bone & joints)
Keshapatana (hair falling)
Shrama (tiredness)
Rukshta (Dryness)
Nakha Vikara (Nail deformity) |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="38" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/10/2024 |
| Date of Study Completion (India) |
19/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="11"
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
Modification(s)
|
Clinical study has obtained Institutional Ethics
committee clearance (GAC/VAD/IEC/90/2024, Date-04/02/2024) and registered at
Clinical trial Registry of India ICMR, New Delhi, Vide CTRI/2024/09/073536, [Registered
on 06/09/2024]. Study single
blind clinical trial. 38 patients were enrolled. Among them 32 patients
were completed the study. The overall
therapeutic assessment revealed that the treatment produced mild to moderate
improvement (34%) in most subjects, with 65.62% showing mild and 6.25% showing
moderate improvement, while no complete or marked cure was observed. Among
individual symptoms, the maximum
improvement was seen in Shrama (39.06%), followed by Asthishula
(38.54%). Moderate relief was noted in Rukshata (15.63%) and Nakha
Vikara (14.06%). Mild improvement was observed in Asthi Sandhi Baddhata
(9.38%) and Sandhi Shaithilya (9.37%), while Keshapatana (5.72%)
showed minimal improvement. Additionally, the
assessment of objective parameters revealed statistically significant
improvement after treatment. Serum Calcium (8.90%) showed a highly significant increase,
while Bone Mineral Density – BMD (6.36%) exhibited a significant improvement. Overall, the therapy showed better efficacy in
reducing Shrama and Asthishula, indicating that the formulation
provided beneficial support in managing the symptoms of Asthikshaya (Osteoporosis).
|