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A Clinical Study of Caraflame Effects on Exercise-Related Muscle Soreness and Inflammation in Healthy participants

A Randomized, Double Blinded, Placebo-Controlled, Parallel Trial to Investigate the Effects of Caraflame-PQNS 505.4mg on Biomarkers of Exercise-Induced Muscle Inflammation in Healthy Human Participants

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/07/113481
Enrollment
24
Registered
2026-07-06
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

None listed

Interventions

Intervention1: Caraflame: Caraflame-PQNS capsule 505.4mg once daily after lunch for 14 days Control Intervention1: Placebo: Placebo

Sponsors

Crassula Healthcare Solutions Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Healthy Human participants of 18- 35 years weighing about 60-70kgs. 2.A body mass index within 18.50- 27.00 Kg/m2 (both inclusive). 3.Given informed consent to participate in the trial 4.Must have baseline serum CK, IL-6 and Myoglobin levels within normal laboratory reference ranges. 5.Must not undergone lower-body strength training in last 03 months. 6.Be Recreationally active but not resistance trained. 7.Must be non-smoker (at least 1 year prior to trial) 8.Participants/LAR must be capable of giving informed consent, and written consent must have been obtained prior to any study procedures. 9.Must be Willing to comply with 14-day pre-loading, Study procedure, visit schedules and protocol requirements in the opinion of investigator.

Exclusion criteria

Exclusion criteria: 1.Hypersensitivity reaction to the study medication 2. Abnormal Creatine Kinase baseline values above upper limit

Design outcomes

Primary

MeasureTime frame
Primary Outcome: Change in levels of Biomarkers of inflammation from Baseline and after exercise on Day 14 Timepoint: Change in levels of Biomarkers of Inflammation post exercise on Day 14 (1.00, 2.00, 3.00, 24.00 and 48.00 Hours) from Base line

Secondary

MeasureTime frame
1. To assess the DOMS (Delayed Onset Muscle Soreness Scale) 2. To monitor the safety of the participants Timepoint: changes in DOMS post exercise on Day 14 from baseline Safety assessment on Day 14 from Baseline

Countries

India

Contacts

Public ContactDr Bhawana Gupta

Crassula Healthcare Solutions Pvt Ltd

bhawana.guptha@crassulapharma.com9903032360

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026