Assesment safety and efficacy of Ayurvedic Formulation AYUSH AGT in external wounds.

Phase 2/3

Not yet recruiting

• Conditions: Other disorders of skin and subcutaneous tissue in diseases classified elsewhere,

• Registration Number: CTRI/2020/04/024658
• Lead Sponsor: Central council for Research in Ayurvedic Sciences

Brief Summary

This study is a An Open Label Clinical Trial to Evaluate Clinical Efficacy and Safety of AYUSH AGT cream for External Wounds. Sufficient quantity of AYUSH AGT cream will apply on open wound for four weeks. Study sample size will be 30 patients. It will be conducted in three centers in India. Primary Outcome Measures is to study time frame required time to complete re-epithelialization and to assess Percentage area of re-epithelialization on day 7, 14, 21and 28 via Bates-Jenson wound assessment tool. Secondary outcome measures to see the Incidence of wound infection while applying AYUSH AGT cream, Pain during dressing changes (score) any systemic effect after treatment CBC, blood glucose, electrolyte, hepatic and renal functions will be analyzed to find any changes, Incidence of Blisterin and to observe incidence Incidence of adverse reactions during treatment

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-08-05
• Study Start: 2020-10-06

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• .1 Patients of either sex with age between 18 and 60 years 2 Patients with Superficial externalwounds requiring dressing 3.
• Solitary wound not less than 1 inches (2.5 cm) in diameter 4 Patienwilling to participate in the study for 1 month.

Exclusion Criteria

• 1Known allergy/hypersensitivity to any of the components of the dressing 2.Wound associated with fracture 3.Wound associated with skin disorder that is chronic or currently active like psoriasis, eczema 4.Neurological deficit at wound site 5.Hemoglobin level <7.0 g/dl, serumalbumin <3 g/dl 6.Patients with concurrent Hepatic Dysfunction (defined as AST and/or ALT > 2 times of the upper normal limit) or Renal Dysfunction (defined as S.Creatinine > 1.2 mg/dl) 7.Known cases of Diabetes Mellitus, AIDS & other sexually transmitted diseases, Malignancy or known history of coagulopathy 8.Patients receiving immune-suppressive medication 9.Pregnancy or lactation 10.Varicose veins/Deep Vein Thrombosis 11.Wounds requiring full thickness graft 12.Patients where a reference wound cannot be treated in isolation fromother wounds.
• 13.H/o hypersensitivity to any of thetrial drugs or their ingredients.
• 14.Patient taking participationin any other clinical trial 15.Any other condition which the Investigatorthinksmay jeopardize the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome Measures	Primary Outcome Measures | Time to complete re-epithelialization (Time Frame: 4 weeks.)
Time to complete re-epithelialization (Time Frame: 4 weeks.)	Primary Outcome Measures | Time to complete re-epithelialization (Time Frame: 4 weeks.)

Secondary Outcome Measures

Name	Time	Method
1.Incidence of wound infection (Time Frame: 4 weeks	2.Pain during dressing changes (score) [Time Frame: 2 weeks]

Trial Locations

Locations (3)

Central Ayurveda Research Institute for Cardiovascular Diseases; 🇮🇳 West, DELHI, India

Regional Ayurveda Research Institute for Skin Disorders, Ahmedabad (RARISD); 🇮🇳 Ahmadabad, GUJARAT, India

Regional Ayurveda Research Institute for Skin Disorders, New Rajeev Nagar, Payakapuram,; 🇮🇳 Krishna, ANDHRA PRADESH, India

Central Ayurveda Research Institute for Cardiovascular Diseases

🇮🇳West, DELHI, India

DrHemant Panigraha

Principal investigator

8368351010

drhemanta71@gmail.com