| CTRI Number |
CTRI/2025/03/083085 [Registered on: 21/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Two-Group Study to Test the Effects of an Ayurveda Treatment on Bone Health in Postmenopausal Women. |
|
Scientific Title of Study
|
A Two-Arm Longitudinal
Randomized Control Trial to Evaluate the Bone Protective Role of an Ayurveda
Formulation in Postmenopausal Females. |
| 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 Ashok Kumar Ahirwar |
| Designation |
Assistant Professor, Department of Laboratory Medicine |
| Affiliation |
AIIMS, Delhi |
| Address |
Department of Laboratory Medicine, AIIMS, Delhi
South
DELHI
110029
India |
| Phone |
9654210832 |
| Fax |
|
| Email |
drashokahirwar@aiims.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Kumar Ahirwar |
| Designation |
Assistant Professor, Department of Laboratory Medicine |
| Affiliation |
AIIMS, Delhi |
| Address |
Department of Laboratory Medicine, AIIMS, Delhi
South
DELHI
110029
India |
| Phone |
9654210832 |
| Fax |
|
| Email |
drashokahirwar@aiims.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Kumar Ahirwar |
| Designation |
Assistant Professor, Department of Laboratory Medicine |
| Affiliation |
AIIMS, Delhi |
| Address |
Department of Laboratory Medicine, AIIMS, Delhi
South
DELHI
110029
India |
| Phone |
9654210832 |
| Fax |
|
| Email |
drashokahirwar@aiims.edu |
|
|
Source of Monetary or Material Support
|
| Advanced Centre for Integrative Health Research in Women and Child Health, Aiims New Delhi-110029 |
|
|
Primary Sponsor
|
| Name |
AyushICMR AdvanAlACIHR at AIIMS under Extramural Program |
| Address |
Ayush-ICMR Advanced Centre for Integrative Health Research in Women and Child Health, AIIMS, New Delhi-110029, India
|
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr ashok ahirwar |
All India Institute of Medical Sciences |
Department of Lab Medicine, Room no-B04, Basement -1, Department of Obstetric and Gynaecology (OPD) Mother and Child Block, Department of Orthopaedics (OPD), New RAK, Department of Geriatric Medicine (OPD), NCA, ANSARI NAGAR, NEW DELHI 110029,
South
DELHI |
9654210832
drashokahirwar@aiims.edu |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institute Ethics Committe All India Institue Of Medical Sciences Room No 102, 1st Floor Old O.T. block, Ansari Nagar, New Delhi 110029 TeZ.No.4579 (Internal), 26594579 (Direct) |
Approved |
| Institute Ethics Committe All India Institue Of Medical Sciences Room No 102, 1st Floor Old O.T. block, Ansari Nagar, New Delhi 110029 TeZ.No.4579 (Internal), 26594579 (Direct) |
Approved |
| Institute Ethics Committe All India Institue Of Medical Sciences Room No 102, 1st Floor Old O.T. block, Ansari Nagar, New Delhi 110029 TeZ.No.4579 (Internal), 26594579 (Direct) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R688||Other general symptoms and signs. Ayurveda Condition: Osteo, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Placebo of Lakshadi Guggulu and Placebo of Mukta shut Pisti | Placebo of Lakshadi Guggulu 500 mg BD and Placebo of Mukta shut Pisti 500 mg OD after having meal for 6 months | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Lakshadi Guggulu, Reference: Ayurvedic Formulary of India, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 6 Months, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Mukta shut Pisti, Reference: Ayurvedic Formulary of India, Route: Oral, Dosage Form: Pishti, Dose: 500(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 6 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
postmenopausal females aged 50-70 years, diagnosed with osteoporosis as per World Health Organization (WHO) criteria, (BMD that lies - 2.5 standard deviation or more below the average value for young healthy women |
|
| ExclusionCriteria |
| Details |
woman suffering from secondary osteoporosis such as inflammatory joint or bowel disorders, current glucocorticoid therapy, chronic kidney disease, malabsorption, untreated endocrine disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in Bone Mineral Density (BMD) at the lumbar spine, femoral neck, and total hip measured using Dual-Energy X-ray Absorptiometry (DEXA).
|
• Baseline (Week 0) – Before starting the intervention
• At 24 Weeks (End of Treatment) – After completion of the 6-month intervention
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This research is designed to provide tailored insights into the potential of Ayurveda formulations for enhancing bone health in menopausal & geriatric females. Positive outcomes could lead to targeted interventions that address the specific needs of these populations, improving their overall quality of life & reducing the burden of osteoporosis- related complications. |
Time Points Baseline, 12 Weeks (Mid of Treatment), 24 Weeks (End of Treatment). |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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)
|
20/05/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Closed to Recruitment of Participants |
| 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 presents a significant challenge
for postmenopausal, geriatric
females and current approaches often overlook the
personalized aspects of health management crucial for this demographic. Ayurveda,
with its emphasis
on individual constitution (Prakriti) and doshic balance, provides a promising avenue yet remains underexplored in geriatric health.
(i)
Novelty:
This study introduces a novel approach
by integrating the principles of Ayurveda, specifically Prakriti and doshic balance, into a rigorous clinical trial.
Addressing the gaps in existing knowledge,
this research aims to provide Ayurveda intervention for menopausal and geriatric
osteoporotic females, acknowledging the diverse constitution and doshic
imbalances within these populations.
(ii)
Objectives:
The primary objective
is to assess the impact of a classical Ayurveda
medicine (Lakshadi guggulu 500 mg tablet,
2 tablets BD with Mukta- shukti Pishti 250 mg twice daily, with water after food for 6 months) on
bone mineral density (BMD) in postmenopausal and geriatric females.
The present study will incorporate the assessment of individual Prakriti
and doshic balance to evaluate the efficacy of Ayurvedic intervention, thereby
emphasizing a comprehensive approach to bone health.
(iii) Methods:
A two-arm
longitudinal randomized control trial will be conducted, randomly assigning 220 participants to the Ayurveda formulation (n=110) or control group (n=110).
Assessments including DEXA scans (t = 0 and 6 months), blood tests (t =
0, 3 and 6 months), will be conducted at various time points.
(iv) Expected Outcome:
Anticipated outcomes include
insights into the efficacy of Ayurveda interventions in preserving and improving BMD,
changes in bone turnover markers, and improved quality of life.
This study aims to contribute valuable evidence, fostering a paradigm shift
towards personalized healthcare approaches for postmenopausal/geriatric females by incorporating Prakriti and
doshic balance, ultimately enhancing
their bone health and overall
well-being. |