Pre clinical and clinical study of Kukkil chooranam(Internal) and Thuvara ennai(External) in the treatment of Varicose ulcer(Nalavibatha viranam)

Phase 2

Not yet recruiting

• Conditions: Having varicose ulcers in legs

• Registration Number: CTRI/2017/05/008584
• Lead Sponsor: NATIONAL INSTITUTE OF SIDDHA

Brief Summary

It is a single non randomized, open label trial to determine the efficacy of kukkil chooranam(Internal) prepared by herbal and mineral constituents and thuvara ennai(External) in patients with nalavibatha pun9Varicose ulcer). In this trial 40 patients will be recruited and the trial drug will be administered 1gm twice a day with honey for a period of 48 days. during the trial period if any AE/SAE/SUSAR will be noticed and refered to pharmacovigilance in NIS and further management will also be given in NIS OPD/IPD. The entire trial will be monitored by the research monitoring committee of NIS. During this trial all the safety efficacy parameters will be recorded in the CRF. After completion of the trial all the study related data will be analysed statistically. The outcome of this trial will be published in India jurnal of Medical research.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2017-05-16
• Study Start: 2017-05-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.Presence of ulcers with varicose veins With or without Pain, Itching, Edema, Fibrinous exudates in the lesions 2.Hyper pigmentation 3.Eczema around the ulcer 4.Inflammation 5.Induration.

Exclusion Criteria

1.Diabetes Mellitus 2.Hansen’s disease 3.Diabetic ulcer 4.Gangrene 5.Tuberculous ulcer 6.Any other systemic illness.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction of varicose ulcer is assessed by Venous clinical severity score (VCSS) and reduction of associated symptoms of Varicose ulcer	every 7 days for 3 months

Secondary Outcome Measures

Name	Time	Method
Reduction of associated symptoms of Varicose ulcer	03 months

Trial Locations

Locations (1)

Ayothidass pandithar hospital; 🇮🇳 Kancheepuram, TAMIL NADU, India

Ayothidass pandithar hospital

🇮🇳Kancheepuram, TAMIL NADU, India

Dr C Sasikala

Principal investigator

7200600640

sasiikala91@gmail.com