CTRI/2025/10/095804Not yet recruitingPhase 2/3
Nutritional analysis of Shramahara Mahakashaya granules and its efficacy in the management of General Debility Syndrome among working women - A Pilot Study
Padmaja Prashant Wanjari1 site in 1 country15 target enrollmentStarted: December 1, 2025Last updated:
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Determination of Nutritional Composition of Shramahara Mahakashya Granules
Study Overview
Brief Summary
The volunteers will be informed about the study protocol. Willing participants will be selected. Clinical research format will be prepared and validated. Prior to the study, approval will be taken from IEC, MGACHRC, Salod (H), Wardha and CTRI registration will be done. After selection, each participant will be assessed individually and selected according to the selection criteria. The study will be carried over a period of 14 days, which will include the treatment period as well as follow ups. Data will be collected and analized accordingly.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 25.00 Year(s) to 45.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Female participants aged 25 to 45 years working in any occupation Mild to Moderate fatigue with FAS score less than 36 Participants willing to participate and give written informed consent.
Exclusion Criteria
- •Women with diagnosed chronic illnesses such as diabetes mellitus, hypertension, thyroid disorders, cardiovascular diseases, chronic fatigue syndrome or autoimmune disorders Participants currently taking nutritional supplements energy boosters or herbal formulations that may interfere with fatigue assessment Women with psychiatric conditions such as depression, anxiety disorders or sleep disorders currently under treatment Women who are pregnant or lactating Women with a history of substance abuse Participants who are unable to comply with the study protocol or follow-up visits.
Outcomes
Primary Outcomes
Determination of Nutritional Composition of Shramahara Mahakashya Granules
Time Frame: 2 months
Secondary Outcomes
- Effectiveness of Shramahara Mahakshaya Granules in General Debility Syndrome in Working Women(2 months)
Investigators
Padmaja Prashant Wanjari
Research Institution and Hospital
Study Sites (1)
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