Clinical study on AQUA-TURMÃ?Â® in muscle soreness

Evaluation of Efficacy and Safety of AQUA-TURMÃ?Â® in Subjects Suffering from Delayed onset muscle soreness (DOMS) Ã¢â?¬â?? A Randomized, Double Blind, Placebo Controlled, Comparative, interventional, Prospective Clinical Study - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/08/035419

Enrollment

Registered

2021-08-04

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

Intervention1: AQUA-TURMÃ?Â® Capsule: AQUA-TURMÃ?Â® Capsule contains water soluble turmeric extract standardized to not less than 30% total Curcuminoids Ã¢â?¬â?? 250 mg Dosage and Treatment Duratio

Eligibility

Inclusion criteria

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

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-TURMÃ?Â® 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

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

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Countries

India

Contacts

Public ContactDr Sanjay Tamoli

Target Institute of Medical Education and Research

targetinstitute@yahoo.com9322522252

Outcome results