Clinical trial on Muscle strength and endurance in male subjects.

Phase 3

• Registration Number: CTRI/2024/07/071339
• Lead Sponsor: KAPIVA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Male volunteers between the age group of 25-45 years.

2.Subjects who are familiar with weight training and had atleast 4 months of experience in the gym (defined as 4 times per week for minimum of 3 to 4 hours per week).

3.Subjects who are willing and able to understand and follow the protocol and provide informed consent.

4.Agree not to use any medication (prescription and over the counter), including vitamins and minerals, and any alternative medications during the course of this study.

5.Subjects whose blood chemistries are within a normal range or not

considered clinically significant if outside the normal range

Exclusion Criteria

1.Concomitant severe decompensated systemic disease (cardiovascular, renal, hepatic, endocrine, hematological, neurological, immunological)

2.Patients with pre-existing severe systemic disease necessitating long-term medication.

3.Subjects suffering from any serious medical or surgical illness.

4.History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ.

5.Any neurological (congenital or acquired), musculoskeletal, joint health conditions, psychological, vascular or systemic disorder which could affect any of the efficacy assessments.

6.Significant abnormal findings as determined by baseline history, physical examination, vital signs (blood pressure, pulse rate, respiration rate), ECG hematology, serum chemistry.

7.More than 4 short courses of oral corticosteroids within the year preceding the screening visit, or any oral corticosteroids in the preceding 4 weeks.

8.Use of Astemizole, Nedocromil, Cromolyn, long acting ß agonists, Ketotifen, Theophylline or testosterone within 4 weeks before.

9.Participation in the current or previous clinical trial with any

approved investigational products during the past 1 month.

Study & Design

• Study Type: Interventional
• Study Design: Not specified