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A Clinical Study to Evaluate the Efficacy and Safety of Ashwagandha Extract Formulation on Improvement of Energy and Endurance in Adults

A Randomized, Double Blind, Placebo Controlled Clinical Study to Evaluate the Efficacy and Safety of Ashwagandha Extract Formulation (ASVAMAN�®) on Improvement of Energy and Endurance in Adults

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/01/039548
Enrollment
40
Registered
2022-01-18
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Manipal Natural Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male healthy adult subjects ranging in age from 18 to 50 years. 2. Willingness to follow the protocol requirements as evidenced by written, informed consent. 3. Mentally, physically and legally eligible to give informed consent 4. Male subjects BMI between 20.0 ââ?¬â?? 25.9 kg/m2 5. Willingness to complete study questionnaires.

Exclusion criteria

Exclusion criteria: 1. Patients with pre-existing severe systemic disease necessitating long-term medication. 2. Significant medical or psychiatric illness 3. History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ 4. Any neurological (congenital or acquired), vascular or systemic disorder which could affect any of the efficacy assessments 5. Participation in the current or previous treatment with any approved or investigational health supplement(s) during the past 1 month. 6. Subjects received other medication (anti-viral) within the 36 hours before entry into the study 7. Patients who had immunization against influenza or influenza like illnesses for that season. 8. Inability to comply with the study protocol, including psychiatric diseases. 9. Immune compromised or with other clinically active illness including cardiac or pulmonary diseases, hemoglobinopathies, renal dysfunction 10. Having vaccination of a seasonal or new influenza A (H1N1) vaccine 6 months before. 11. Other reasons that researchers think not fitting to participate in the study 12. Evidence of significant uncontrolled comorbid disease which in the investigators opinion would jeopardize patient participation. 13. Patient tested positive with Covid 19

Design outcomes

Primary

MeasureTime frame
Change from baseline to the end of the study period in Serum CortisolTimepoint: Day 0 and Day 42

Secondary

MeasureTime frame
Change from baseline to the end of the study period in 30 Meter walk testTimepoint: Day 0, Day 21 and Day 42;Change from baseline to the end of the study period in Chair Stand TestTimepoint: Day 0, Day 21 and Day 42;Change from baseline to the end of the study period in One Leg Stand TestTimepoint: Day 0, Day 21 and Day 42;Change from baseline to the end of the study period in Quality of Life ââ?¬â?? SF 36Timepoint: Day 0, Day 21 and Day 42;Change from baseline to the end of the study period in Six Minutesââ?¬â?¢ walk testTimepoint: Day 0, Day 21 and Day 42;Change from baseline to the end of the study period in Stair Climb TestTimepoint: Day 0, Day 21 and Day 42;Change from baseline to the end of the study period in TestosteroneTimepoint: Day 0 and Day 42

Countries

India

Contacts

Public ContactMr Manohar Divanji Shriranga

Manipal Natural Private Limited

shiv@manipalnatural.com8971489704

Outcome results

None listed

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