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Evaluation of safety and Efficacy of Chymoral Forte in wound healing potential after orthopaedic surgery.

Comparative Evaluation Of Trypsin:Chymotrypsin (6:1) Versus Serratiopeptidase For Their Healing Potential In Surgical Wounds After Orthopedic Surgery: Open, Prospective, Randomized, Comparative Study"

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/07/001920
Enrollment
75
Registered
2011-07-26
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Post orthopaedic surgery patient

Interventions

Intervention1: Chymoral Forte: Tablet containing Trypsin:Chymotrypsin (6:1) containing 1,00,000 Armour Units (AU) of enzymatic activity Dose: One tablet 3 times in a day orally for 7 ? 10 days. Contr

Sponsors

Elder Pharmaceuticals Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient of either sex between 18 to 60 years of age 2. Patient to undergo elective clean and uncontaminated surgery for open reduction of fracture 3. Patients willing to take the medications as directed 4. Willing to comply with the protocol requirements 5. Willing to give the written informed consent

Exclusion criteria

Exclusion criteria: 1. Patients with known hypersensitivity to any of the study related drugs (i.e. trypsin-chymotrypsin , serratiopeptidase , Bromelain & Rutoside) 2. Patients undergoing emergency surgery & those with contaminated surgery 3. Patients with known hepatic or renal impairment 4. Patients not willing to give written informed consent 5. Uncontrolled diabetes mellitus or any other metabolic disorder. 6. Pediatric and Pregnant patients. 7. Treatment with any investigational drug in the preceding 4 weeks. 8. Any other condition that, in the opinion of the investigator, does not justify the inclusion of the subject in the study.

Design outcomes

Primary

MeasureTime frame
Composite score for surgical wound assessment based on the following symptoms & signs: - Erythema - Local Irritation - Discharge - Edema - Induration - Tenderness Timepoint: Day 3 day 5 day 7 day 10

Secondary

MeasureTime frame
Pain: Granulation tissue: Global Response Assessment: Timepoint: day 3 day 5 day 7 day 10

Countries

India

Contacts

Public ContactMr Raj Sethi
drdebra@elderindia.com02226730058

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 11, 2026