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

Phase 2/3

Completed

• Conditions: Age-related osteoporosis without current pathological fracture,

• Registration Number: CTRI/2019/06/019792
• Lead Sponsor: National innovation foundation

Brief Summary

This randomized multi arm controlled, single blind clinical trial was done for safety and efficacy of two grassroots leads  in the management of osteopenia/ osteoporosis among postmenopausal women. Two grassroots leads in two different formulation and in two different doses were compared against standard *Ayurvedic* drug and standard allopathic drug.Each group was given one year of medication.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-07
• Study Completion: 2024-03-08
• Last Update Posted: 2025-02-20

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 360

Inclusion Criteria

• 1.Postmenopausal women, defined as no menstruation for the last 12 months.
• 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

• 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.
• 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.
• Patient suffering from uncontrolled DM-2 or uncontrolled hypertension.
• Patients suffering from Osteomalacia.
• Patients suffering from Malabsorption syndrome 10.
• Patients undergone Organ transplantation or on immunosuppressive therapy 11.
• Prolonged immobilization 12.
• Patients whose Serum Ca++ level < 2.2 or > 2.6 mmol/L (< 9 or >10.5 mg/dL) 13.
• History of renal stones 14.
• Long bone fracture in last 6 months.
• Patient not ready to give an informed consent 16.
• Subjects who has participated in any other clinical study in last 30 days.
• Patients with clinical evidence of active and chronic illness as rheumatoid arthritis, gout,SLE, Psoriatic arthritis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	1 year

Secondary Outcome Measures

Name	Time	Method
To assess the biomarker response for bone formation of study drugs in postmenopausal osteoporosis
Mean changes in quality of life among women suffering from postmenopausal osteoporosis	1 year

Trial Locations

Locations (1)

Madhav Vilas Hospital, National Institute of Ayurveda,Jaipur,; 🇮🇳 Jaipur, RAJASTHAN, India

Madhav Vilas Hospital, National Institute of Ayurveda,Jaipur,

🇮🇳Jaipur, RAJASTHAN, India

Professor Sanjeev

Principal investigator

8290996996

profsanjeevhp@gmail.com