A clinical study to see the effect of some Ayurvedic formulations in the patients of Bone loss.

Phase 2

Recruiting

• Conditions: Osteopenia/Osteoporosis

• Registration Number: CTRI/2012/07/002775
• Lead Sponsor: Department of AYUSH Ministry of Health Family Welfare Government of India

Brief Summary

Aimed at scientific validation of the clinical efficacy and safety of twenty nine (29) classical Ayurvedic pharmacopoeial formulations, multicentre clinical trials have been initiated as an activity under the Ayurveda Clinical Trials (ACT) project of the Ayurvedic Pharmacopoeia Committee (APC) during August 2010 in eighteen (18) disease conditions involving fifty four (54) M.D/PhD (Ay.) research scholars in eight (08) postgraduate Ayurveda colleges across the country.

**Laksha Guggulu**, a polyherbal Ayurvedic formulation containing Laksha (Laccifer lacca), Asthisamhrt (Cissus quadrangularis), Asvagandha (Withania somnifera), Nagabala (Sida veronicaefolia) and Guggulu (Commiphora wightii).

**Mukta Shukti Pishti** is air dried powder of Mukta and Shukti with the help of Gulab Jala.

**Laksha Guggulu** and **Mukta Shukti Pishti** have been in use since ages and found to be useful in treating Osteopenia/Osteoporosis and promoting the health. The present study is being undertaken in three post graduate Ayurveda colleges involving the post graduate scholars who would be doing the clinical trials to scientifically study and validate the clinical efficacy and safety of these Ayurvedic formulations as a part of their Post Graduate (PG) Thesis.

The **Central Council for Research in Ayurvedic Sciences (CCRAS)** is the nodal organization to co-ordinate and monitor these trials. CCRAS has provided the necessary infrastructure to the participating colleges, technical inputs (including the clinical trial protocols), trial drugs and training to the researchers involved in the project.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-21
• Last Update Posted: 2012-01-18

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• 1 Patients of either sex between 45 to 65 years of age.
• Score of < -1 3 Willing and able to participate for 16 weeks.

Exclusion Criteria

• Patients who are consuming any drug which is known to affect bone metabolism for e.g. SERMs, bisphophonates, calcitonin, Vit.D (more than 60,000 units) and corticosteroids (more than 5mg/day of prednisolone or equivalent) for more than 3 months, methotrexate, anti- convulsants, diuretics, etc 2.
• Patients with history of Fragility Fracture.
• Patients suffering from congenital disorders (Dysosteogenesis and Marfan’s Syndrome) 4.
• Patients with endocrine disorders (Hyperthyroidism, hyperparathyroidism, Untreated Cushing‘s syndrome) 5.
• Patients with poorly controlled Hypertension ( > 160 / 100 mm Hg) 6.
• Patients suffering from Osteomalacia.
• Patients suffering from Malabsorption syndrome 9.
• Patients who have undergone Organ transplantation 10.
• Patients who are immobilized since > 6 weeks 11.
• Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
• Symptomatic patient with clinical evidence of Heart failure.
• Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT > 3 times of the upper normal limit) or Renal Dysfunction (defined as S.
• creatinine > 1.2mg/dl), uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease.
• Patients with poorly controlled Diabetes Mellitus (HbA1c > 10%) 16.
• Alcoholics and/or drug abusers.
• Patients with evidence of malignancy 18.
• Pregnant or lactating woman.
• H/o hypersensitivity to any of the trial drugs or their ingredients 21.
• Patients who have completed participation in any other clinical trial during the past six (06) months.
• Any other condition which the P.I. thinks may jeopardize the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
• Change in Quality of Life index (QUALEFFO-41)	At Baseline, at 84th day and at the end of follow up after 16 weeks

Secondary Outcome Measures

Name	Time	Method
• Change in Bone Mineral Density (T-score)	At Baseline and at the 84th day.

Trial Locations

Locations (3)

National Institute of Ayurveda (NIA), Jaipur; 🇮🇳 Jaipur, RAJASTHAN, India

Rajiv Gandhi Government Post-Graduate Ayurvedic College, Paprola; 🇮🇳 Kangra, HIMACHAL PRADESH, India

Shri Dharmasthala Manjunatheswara (SDM) College of Ayurveda, Hassan; 🇮🇳 Hassan, KARNATAKA, India

National Institute of Ayurveda (NIA), Jaipur

🇮🇳Jaipur, RAJASTHAN, India

Prof H K Kushwaha Dr Uttam Kumar

Principal investigator

drhkkushwah@gmail.com