A clinical study of Vranari Guggulu and Vrana lepa in the management of Diabetic Foot Ulcer

Phase 2

Recruiting

Conditions: Diabetic Foot Ulcer

Registration Number: CTRI/2015/02/005586

Lead Sponsor: DrNRS GovtAyurvedic College

Brief Summary: A clinical trial is initiated to generate evidence for the scientific validation of the clinical efficacy and safety of classical Ayurvedic formulation Vranari Guggulu twp tablets(500mg) and Karanjadi Vranalepa(external application) in Madhumehajanya Vrana (Diabetic Foot Ulcer) at Dr.NRS Govt. Ayurvedic College, Vijayawada for the PhD study under Dr.NTR University of Health Sciences, Vijayawada. In the study Vranari Guggulu 500 mg b.i.d. internal administration and Karanjadi Vrana lepa as external application given for Group I patients (i.e. 50 patients), Kanchanara Guggulu 500 mg b.i.d. internal administration and Vajraka thailam as external application given for Group II patients (another 50 patients). This study will be conducted in India and completed in 4 years duration. The primary outcome measures will be relief in signs and symptoms, Mean percentage change in wound area, Recognized clinical prognostic factors like reduction in wound area, depth and wound healing. Proportion of patients with complete wound closure (i.e. complete skin epithelialization) after initiation of study treatment. Any adverse drug reaction or event occurs during the trial also will be documented. Kanchanara Guggulu consists of bauhinia varigata, terminalia chebula, terminalia bellerica, emblica officinalis, zingiber officinale, piper nigrum, piper longum, crataeva nurvala, elettaria cardamomum, cinnamomum zeylanicum, commiphora mukul. Vajraka thailam consists of saptaparna, karanja, malathi, chitraka, sariva, vatsaka, langali and gomutra and thailam. Vranari Guggulu consists of pippali(piper logum) 1 part, guggulu(commiphora mukul)5parts, triphala each 3 parts, rasa sindura 1 part. Karanjadi vrana lepa consists of sasi(camphor) 1 part, Girivara 2 parts, Tutha(CuSo4) 3 parts, yashti(glycerrhiza) 4 parts, bakuchi(psoralia) 5 parts Karanja 6 parts.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 100

Inclusion Criteria

1.Patients of both sexes between the age group of 18-60 yrs.
2.Type I and II DM 3.Clinically Diagnosed as Diabetic Foot Ulcer 4.Target ulcer duration more than 30 days.

Exclusion Criteria

1.H/o Infectious and systemic diseases 2.Ulcer on heel 3.Ulcer with exposed bone and tendon 4.Immune deficiency 5.Coagulation disorders 6.Cellulitis 7.Gangrene 8.Presence of underlying Osteomyelitis 9.Pregnant women 10.Malignancies.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean percentage change in wound area,pain	Treatment period : 45 days \| Assessment in every week \| Active follow up : 45 days
Recognized clinical prognostic factors like reduction in wound area and depth and wound healing	Treatment period : 45 days \| Assessment in every week \| Active follow up : 45 days
Proportion of patients with complete wound closure	Treatment period : 45 days \| Assessment in every week \| Active follow up : 45 days

Secondary Outcome Measures

Name	Time	Method
Improve general condition of the patient	wound healing

Trial Locations

Locations (1): Division of Shalya
🇮🇳
Krishna, ANDHRA PRADESH, India
Division of Shalya
🇮🇳Krishna, ANDHRA PRADESH, India
Dr Ch V S Koteswara Rao
Principal investigator
9441072007
ayurdoctor007@gmail.com