| CTRI Number |
CTRI/2025/10/096025 [Registered on: 14/10/2025] Trial Registered Prospectively |
| Last Modified On: |
13/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Development of Shalmali pushpa (Bombax ceiba L.) granules and to see its effect in the low bone density in postmenopausal women by clinical trial |
|
Scientific Title of Study
|
Development and evaluation of Shalmali pushpa (Bombax ceiba L.) granules in the management of Asthikshaya (osteopenia) in postmenopausal women: An Exploratory clinical 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 Aarti Raghav |
| Designation |
PG Scholar |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
Room no.-219, Academic block, Second floor, Department of Dravyaguna, All India Institute of Ayurveda, Sarita Vihar, New Delhi
South
DELHI
110076
India |
| Phone |
7011042354 |
| Fax |
|
| Email |
aartiraghav1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meena S Deogade |
| Designation |
Additional professor |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
Room no.-201, Academic block, Second floor, Department of Dravyaguna, All India Institute of Ayurveda, Sarita Vihar, New Delhi
South
DELHI
110076
India |
| Phone |
09220445351 |
| Fax |
|
| Email |
drmmeena@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meena S Deogade |
| Designation |
Additional professor |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
Room no.-201, Academic block, Second floor, Department of Dravyaguna, All India Institute of Ayurveda, Sarita Vihar, New Delhi
South
DELHI
110076
India |
| Phone |
09220445351 |
| Fax |
|
| Email |
drmmeena@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda, Sarita Vihar, New Delhi-110076,India |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi-110076 |
| 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 Aarti Raghav |
All India Institute of Ayurveda |
OPD, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi
South
DELHI |
07011042354
aartiraghav1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
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 | Other than Classical | | (1) Medicine Name: Shalmali granules, Reference: NA, Route: Oral, Dosage Form: Khanda/Granules, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1.Female subjects between age group of 45-65 years irrespective of caste and religion.
2.Patients having BMD score between -1 to -2.5 with clinical features of asthikshaya.
3.Those subjects who will be ready to sign informed consent form.
4.Subjects who are not taking any type of Calcium supplementation for more than 6 months.
|
|
| ExclusionCriteria |
| Details |
1.Subjects not willing for trial & follow up
2.Patients having BMD score between -2.5 to -3.0 (Osteoporosis) and -3 and lower (Severe osteoporosis)
3.Hyper or Hypothyroidism
4.Subjects on Multi-vitamin or calcium supplementation
5.Patients having any systemic disease or history of chronic diseases such as diabetes mellitus, tuberculosis, cancer and autoimmune diseases
6.Subjects with acute and chronic infections, Mal-absorption syndrome and Inborn errors of metabolism
7.Patients who have completed participation in any other clinical trial during the past 2 months
8. Patient receiving HRT.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To develop a standardized dosage form (granules) of Shalmali pushpa
2.To assess the improvement in BMD score and serum calcium levels
|
Baseline, 30 days, 60 days, 90 days,120 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Development of a preliminary analytical profile of Shalmali pushpa granules. |
Baseline, 30 days, 60 days, 90 days,120 days |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
03/03/2026 |
| 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
|
This exploratory clinical study is designed to develop and evaluate Shalmali Pushpa (Bombax ceiba L.) granules for the management of Asthikshaya (osteopenia) in postmenopausal women. Twenty four participants between 45 to 65 years of age with a BMD T score of –1 to –2.5 will receive 10 g of the granules twice daily for 90 days followed by a 30 day post treatment follow up.The study aims to provide a safe and effective herbal intervention that integrates traditional Rasayana principles with modern diagnostic evaluation for postmenopausal bone health. |