Development of Shalmali pushpa (Bombax ceiba L.) granules and to see its effect in the low bone density in postmenopausal women by clinical trial

Development and evaluation of Shalmali pushpa (Bombax ceiba L.) granules in the management of Asthikshaya (osteopenia) in postmenopausal women: An Exploratory clinical study. - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/10/096025

Enrollment

Registered

2025-10-14

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M859- Disorder of bone density and structure, unspecified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
1.To develop a standardized dosage form (granules) of Shalmali pushpa 2.To assess the improvement in BMD score and serum calcium levels Timepoint: Baseline, 30 days, 60 days, 90 days,120 days	—

Secondary

Measure	Time frame
1.Development of a preliminary analytical profile of Shalmali pushpa granules.Timepoint: Baseline, 30 days, 60 days, 90 days,120 days	—

Countries

India

Contacts

Public ContactDr Meena S Deogade

All India Institute Of Ayurveda

drmmeena@rediffmail.com09220445351

Outcome results