Effect of Muktashukti Bhasma and Saubhagyashunti on the bone health of Nursing Mother Health consuming Traditional Diet food in Maharashtra.

Phase 2

Registration Number: CTRI/2024/05/067814

Lead Sponsor: Central Council for Research In Ayurvedic Sciences, New Delhi

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Married, apparently healthy, currently lactating mothers 21 - 40 years of age

2. Willing to continue exclusive breastfeeding their infant for at least 6 months post-delivery and partially breastfeed later on throughout the study period

3. The infant is less than 30 days at screening

4. Mother and infant are in good health, as determined by the study investigator

5. Willing to prevent conception (by use of a contraceptive) till the study period

6. Willing and able to participate in all aspects of the study including allocation of any of the study drugs – Mukta Shukti Bhasma and Saubhagya Shunthi or calcium citrate & Vitamin D supplements, follow-up visits and the procedures thereof, study retention period (12 months since recruitment),

7. Willing to provide informed written consent

Exclusion Criteria

1. Currently on medication that affects Vitamin D metabolism like Steroids, anticonvulsants, or barbiturates etc.

2. Nursing Mutiple twins or have had any complication during the latest parturition or have had bad obstetric history

3. Taking greater than the daily recommended intake of 1000 mg elemental calcium as calcium supplements

4. Mother with baseline 25(OH)D levels greater than 70ng/ml

5. Women using contraceptives like medroxyprogesterone acetate, oral contraceptives

6. Infant weight below 2kg at the time of recruitment in the study

7. Advised or willing to undergo any major surgery during the study period

8. History of Hypo/Hyperthyroidism, Diabetes mellitus

9. History of urolithiasis or any other disease condition (like cardiovascular, pulmonary disease, rheumatoid arthritis or any other auto-immune or chronic inflammatory disease) or known hypersensitivity to any of the trial drugs or their ingredients that may jeopardize the study

10. Not residing in the locality accessible for the research staff for follow up visits

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Clinical Efficacy: Comparison of change and time trend analysis in the BMD at lumbar spine (L1 to L4), Dual Femur (neck and total ) and left Radius (33% and ultra-distal) among the Mukta Shukti Bhasma with Saubhagya Shunthi Vs Calcium citrate with vitamin D supplemented groups of women. <br/ ><br>2. Comparison of the effect of the trial drugs on Bone Metabolism parameters (ionic calcium, phosphorus, magnesium, 25 hydroxy vitamin D, intact parathormone, Bone specific alkaline phosphatase, CTX, P1NP) in lactating women <br/ ><br> <br/ ><br>Timepoint: 1. Baseline, 6 months and 12 months <br/ ><br>2.1. Bone-specific alkaline phosphatase, CTX, P1NP - Baseline, 3 months, 6 months and 12 months <br/ ><br>2.2. ionic calcium, phosphorus, magnesium, 25 hydroxy vitamin D, intact parathormone - Baseline and 12 months <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1. Incidence of Treatment emergent adverse events in both groups <br/ ><br>2. Drug compliance achieved in both groups <br/ ><br>3. Time trend analysis of the association of dietary macronutrients on the body composition parameters like Visceral Adiposity Tissue, android fat mass, gynoid fat mass, anthropometric measurements among the participants in both groups <br/ ><br>4. Improvement in Quality of Life as assessed by MAPP-QOL among the participants in both groups. <br/ ><br>Timepoint: For 1, 2 and 4 - Baseline, 3 months, 6 months, 9 months and 12 months <br/ ><br>For 3 - Baseline, 6 months and 12 months