Clinical trial for safety and efficacy of grassroots leads in the management of Osteopenia / Osteoporosis among postmenopausal women.

A randomized controlled, single blind clinical trial for safety and efficacy of grassroots leads in the management of Osteopenia / Osteoporosis among postmenopausal women

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/06/019792

Enrollment

360

Registered

2019-06-20

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

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

Conditions

Health Condition 1: M810- Age-related osteoporosis without current pathological fracture

Interventions

Intervention1: Group 3 - NIF herbal grassroots lead 1 formulation 1: NIF herbal grassroots lead 1 formulation 1 in lower dose for one year Intervention2: Group 4 – NIF herbal grassroots lead 1 formula

Eligibility

Inclusion criteria

Inclusion criteria: 1.Postmenopausal women, defined as no menstruation for the last 12 months. 2. B.M.D.T. Score -1 to -3.5 at hip, spine and forearm (worst score at any of the three sites to be considered)

Exclusion criteria

Exclusion criteria: 1. B.M.D. T. score above -1 and less than -3.5 2. All women who are consuming any drug which is known to affect bone metabolism in doses for e.g. SERMs, bisphophonates, calcitonin, Vit. D more than 60,000 units and corticosteroids more than 5mg/day for more than 3 months, methotrexate, anticonvulsants and diuretics. 3. Patients suffering from congenital disorders (Dysosteogenesis and Marfan.s Syndrome) 4. Patients with endocrine disorders (Hyperthyroidism, hyperparathyroidism, Untreated Cushing.s syndrome) 5. Patients with evidence of malignancy 6. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Epilepsy) 7. Patients suffering from chronic hepatic disorder, renal failure or cardiac dysfunction. 8. Patient suffering from uncontrolled DM-2 or uncontrolled hypertension. 8. Patients suffering from Osteomalacia. 9. Patients suffering from Malabsorption syndrome 10. Patients undergone Organ transplantation or on immunosuppressive therapy 11. Prolonged immobilization 12. Patients whose Serum Ca++ level 2.6 mmol/L ( 10.5 mg/dL) 13. History of renal stones 14. Long bone fracture in last 6 months. 15. Patient not ready to give an informed consent 16. Subjects who has participated in any other clinical study in last 30 days. 17. Patients with clinical evidence of active and chronic illness as rheumatoid arthritis, gout,SLE, Psoriatic arthritis.

Design outcomes

Primary

Measure	Time frame
To compare the safety and efficacy of Grassroots leads with Ayurvedic drug (Lakshadi Guggulu and Praval Pishti) and Allopathic drug(Shalcal) in subject with postmenopausal osteoporosis.Timepoint: 1 year	—

Secondary

Measure	Time frame
To assess the biomarker response for bone formation of study drugs in postmenopausal osteoporosis Timepoint: 1 year;Mean changes in quality of life among women suffering from postmenopausal osteoporosisTimepoint: 1 year	—

Countries

India

Contacts

Public ContactDr Sarvesh Kumar Singh

National institute of Ayurveda,Jaipur

sarveshksingh21@gmail.com8739860237

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026