Clinical study on AQUA-TURM�® in muscle soreness

Phase 2

Completed

• Registration Number: CTRI/2021/08/035419
• Lead Sponsor: odaat Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-10-25
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

1.Moderately active (regular aerobic exercise for at least 4 hours per week) healthy human volunteers

2.Subjects with no known musculoskeletal pathology

3.Subjects willing to sign informed consent and to undergo all the study procedure.

Exclusion Criteria

1.Subjects with no known musculoskeletal pathology

2.Subjects using systemic corticosteroids within 2 months of screening

3.Subjects with any other investigational drug within 1 month prior to randomization;

4.Subjects with uncontrolled diabetes mellitus and hypertension

5.Subjects with known tuberculosis, HIV, ischemic heart disease, cancer, kidney failure

6.Pregnant and lactating women

7.Subjects with significant abnormal laboratory parameters

8.Known hypersensitivity to any of the ingredients of AQUA-TURM�®

9.Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his/her participation in, and completion of the protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1). Comparative change in muscle pain on VAS between two groups <br/ ><br>2) Comparative change in muscle tenderness between two groups <br/ ><br>Timepoint: First Sub Set of the Study: <br/ ><br> <br/ ><br>0 Hour, 6 hour, Day 2 (24 <br/ ><br>hour) , Day 3 (48 hour) <br/ ><br> <br/ ><br>Second Sub Set of the Study: <br/ ><br> <br/ ><br>Day 1, Day 2, Day 2.5 (Baseline), 24 hour post baseline, 48 hour post baseline <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1). Comparative change in muscle swelling <br/ ><br>2). Comparative change in jump performance <br/ ><br>3). Comparative change in Creatinine Kinase and CRP <br/ ><br>4) Comparative assessment of requirement of Paracetamol or NSAIDs as rescue medicine <br/ ><br>5). Comparative change in global assessment for overall change by investigator and subject <br/ ><br>6). Comparative assessment of tolerability of study product by investigator and subject. <br/ ><br>7). Adverse events assessment <br/ ><br>Timepoint: First Sub Set of the Study: <br/ ><br> <br/ ><br>0 Hour, 6 hour, Day 2 (24 <br/ ><br>hour) , Day 3 (48 hour) <br/ ><br> <br/ ><br>Second Sub Set of the Study: <br/ ><br> <br/ ><br>Day 1, Day 2, Day 2.5 (Baseline), 24 hour post baseline, 48 hour post baseline <br/ ><br>