A clinical study to see the effect of Ayurvedic formulation Godhum Satva in the form of oral administration in the treatment of Osteoporosis with respect to Bone Mineral Density in females.

A comparative study to evaluate the effect of Godhum Satva over calcium supplement in the prevention of osteoporosis with special referene to Bone Mineral Density in females.

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/07/035205

Enrollment

Registered

2021-07-28

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-01

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: Godhum Satva: It is a formulation of Ayurvedic herb prepared in the form of capsule for oral administarion containing Godhum Satva along with life style modification. This formulation w

Eligibility

Inclusion criteria

Inclusion criteria: 1)Female patients of age between 40 - 60 years, irrespective of their religion and occupation. 2)Bone Mineral Density between 1 to 2.5 SD below the young adult mean.

Exclusion criteria

Exclusion criteria: 1)Subjects with known case of hypertension, cardiovascular diseases. 2)Subjects having Endocrine function impairment e.g., hyperthyroidism, para hyperthyroidism 3)Subjects known case of irritable bowel syndrome, gluten intolerance and other gut absorption impairing disease. 4)Subjects having long standing corticosteroid treatment. 5)Subjects with previous history of one or more fracturs due to falling or any mild impact

Design outcomes

Primary

Measure	Time frame
A comparative study to evaluate the effect of Godhum Satva over calcium supplement in prevention of osteoporosis with special reference to Bone Mineral Density in females. parameters of efficacy will be the changes in before and after Bone Mineral Densities measured from patients "heel" by portable calscan device.Timepoint: The drug will be given for 60 days. Patient will be assesed on Day 1, Day 15, Day 30, Day 45, Day 60th of the treatment respectively. Total duration of the study will be 18 months.	—

Measure

Time frame

A comparative study to evaluate the effect of Godhum Satva over calcium supplement in prevention of osteoporosis with special reference to Bone Mineral Density in females. parameters of efficacy will be the changes in before and after Bone Mineral Densities measured from patients "heel" by portable calscan device.Timepoint: The drug will be given for 60 days. Patient will be assesed on Day 1, Day 15, Day 30, Day 45, Day 60th of the treatment respectively. Total duration of the study will be 18 months.

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Secondary

Measure	Time frame
A comparative study to evaluate the effect of Godhum Satva over calcium supplement in prevention of osteoporosis with special reference to Bone Mineral Density in females. parameters of efficacy will be the changes in before and after Bone Mineral Densities measured from patients "heel" by portable calscan device. secondary outcome will be relief in Asthikshaya Lakshanas.Timepoint: The drug will be given for 60 days. Patient will be assessed on Day 1, Day 15, Day 30, Day 45, Day 60th of the treatment respectively. Total duration of the study will be 18 months.	—

Measure

Time frame

A comparative study to evaluate the effect of Godhum Satva over calcium supplement in prevention of osteoporosis with special reference to Bone Mineral Density in females. parameters of efficacy will be the changes in before and after Bone Mineral Densities measured from patients "heel" by portable calscan device. secondary outcome will be relief in Asthikshaya Lakshanas.Timepoint: The drug will be given for 60 days. Patient will be assessed on Day 1, Day 15, Day 30, Day 45, Day 60th of the treatment respectively. Total duration of the study will be 18 months.

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Countries

India

Contacts

Public ContactVd Sarita Ramakant Murade

Sumatibhai Shah Ayurved Mahavidyalaya

dr.niteshjoshi@rediffmail.com7020672358

Outcome results

None listed

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