Health Condition 1: M791- Myalgia
Conditions
Interventions
Intervention1: Immediate Release Curcuminoids - Zing 95 -200 mg of 95% Curcuminoid: One capsule orally, once daily after 1 hour of exercise, for 7 days.
Control Intervention1: Curcumin 95% - 500 mg
Sponsors
MAKAMS Industries Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy human volunteers aged between 21 years to 35 years 2. The study will include trained candidates who have not performed any exercise in the last 2 months. 3. Participants with no known musculoskeletal pathology 4. Participants willing to sign informed consent and to undergo all the study procedure.
Exclusion criteria
Exclusion criteria: 1. Participants using systemic corticosteroids within 2 months of screening 2. Participants with any other investigational drug within 1 month prior to randomization; 3. Participants with uncontrolled diabetes mellitus and hypertension 4. Participants with known tuberculosis, HIV, ischemic heart disease, cancer, kidney failure 5. Pregnant and lactating women 6. Participants with significant abnormal laboratory parameters 7. Known hypersensitivity to any of the ingredients of test product 8. Other conditions, which in the opinion of the investigators, makes the participant unsuitable for enrolment or could interfere with his/her participation in, and completion of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in muscle pain on VAS The change in muscle tenderness by VAS tenderness on palpation Assessment of change in muscle swelling Assessment of change in jump performance Power output To evaluate the reduction in tiredness and fatigue measured with Chalder Fatigue Scale Assessment of Delayed Onset Muscle Soreness will be conducted To measure change in Lean Body Mass (LBM) and Muscle Mass by CULT Smart Scale PROTimepoint: Day 0 (baseline), Day 1, Day 3, Day 5(Telephonic Discussion) and Day 7. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of change in Creatinine Kinase ,CRP , LDH after 1 hours of exercise. To evaluate the improvement in energy levels by measuring VO2 max through Downhill Treadmill test Assessment of endurance by 6 Minute Walk Test will be conducted Assessment of requirement of Paracetamol or NSAIDs as rescue medicine The overall change in condition will be assessed on Day 7 using a 5-point Likert-type scale by both the investigator & the participant. Assessment of tolerability of study product by investigator & participant. Adverse events assessmentTimepoint: Day 0 (baseline), Day 1, Day 3, Day 5(Telephonic Discussion) & Day 7. | — |
Countries
India
Contacts
Public ContactDr Gayathri Sivakumar
Ki3 PRIVATE LIMITED
Outcome results
None listed