Effect of paste of nimbadi kalka (paste of neem leaves, tila seeds, honey and ghee) on foot ulcers caused due to diabetes.

Phase 1/2

Completed

• Conditions: Non-pressure chronic ulcer of heeland midfoot,

• Registration Number: CTRI/2018/02/012255
• Lead Sponsor: Amrita School of Ayurveda

Brief Summary

The research workentitled “**Open Label Clinical Trial to Assess the Efficacy of *NimbadiKalka* in Diabetic Foot Ulcerâ€** was carried out in the OPD and IPD ofAmrita School of Ayurveda and Amrita Institute of Medical Science, on 15patients. They were assessed on the basis of Pain, Granulation tissueformation, Exudate, and reduction in Wound Size on the 15th, 30th,and 45th day. Based on the study following conclusions can be drawn-

·       *NimbadiKalka* possesses properties such as antioxidant,anti-inflammatory, and anti-microbial and it also maintains the moisture balance ofthe wound environment. These help in reducing the inflammatory phase of the chronic wound and thereby promotes the proliferation and remodeling phase.

·       Ithas been proven beneficial in the reduction of exudate, pain, and wound size. Therewas 100% relief in pain, 95% reduction in exudate, and 88% in wound size, and after15 days of treatment, there is an improvement in granulation tissue formation.

·       Also,the drug is easy to prepare and can be applied to any group of patients due toits better availability and safety.

·       Noadverse drug reaction (ADR) and side effects were reported during the course oftreatment so the drug in the form of paste as the external or topical applicationis safe.

·       Therefore,it may be recommended that this low-cost, easily prepared; an application may be prescribedfor routine use for wound healing purposes, especially in diabetic wounds.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-03
• Study Completion: 2019-10-28
• Last Update Posted: 2022-11-25

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1)HbA1c between 6-7 % 2)Wound penetrating to tendons associated with signs of infection (Texas B2 Classification) 3)Wound sites:- plantar surface of foot and toes (metatarsal heads and mid foot), dorsal interphalangeal joints.

Exclusion Criteria

1)Age below 40 years and above 70 years 2)HbA1c above 7 3)More than B2 Texas classification 4)Wound anywhere except dorsal and plantar region 5)Patients with other systemic pathology (TB, HIV, HBsAg, VDRL, Malignancy) 6)Patient on other medications like steroids.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1)Reduction in wound size assessed by wound tracing sheet	45 days

Secondary Outcome Measures

Name	Time	Method
1)Effect on wound discharge assessed by the soak-age of gauze pad	2)Effect on granulation tissue formation assessed using photo documentation

Trial Locations

Locations (1)

Amrita School of Ayurveda; 🇮🇳 Kollam, KERALA, India

Amrita School of Ayurveda

🇮🇳Kollam, KERALA, India

Saranya V Nair

Principal investigator

7012183609

saranyav.nair@gmail.com