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CTRI Number  CTRI/2018/02/012255 [Registered on: 28/02/2018] Trial Registered Prospectively
Last Modified On: 25/11/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect of paste of nimbadi kalka (paste of neem leaves, tila seeds, honey and ghee) on foot ulcers caused due to diabetes. 
Scientific Title of Study   Open label clinical trial to study the efficacy of Nimbadi Kalka in Diabetic Foot Ulcer. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Saranya V Nair 
Designation  1st year PG Scholar 
Affiliation  Amrita School of Ayurveda 
Address  Department of Shalya Tantra, School of Ayurveda, Amrita University, Vallikavu, Clappana P.O, Kollam

Kollam
KERALA
690525
India 
Phone  7012183609  
Fax    
Email  saranyav.nair@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Rabinarayan Tripathy 
Designation  Head of the Department 
Affiliation  Amrita School of Ayurveda 
Address  Department of Shalya Tantra, School of Ayurveda, Amrita University, Vallikavu, Clappana P.O, Kollam

Kollam
KERALA
690525
India 
Phone  8129292391  
Fax    
Email  drrabi73@gmail.com  
 
Details of Contact Person
Public Query  
Name  Saranya V Nair 
Designation  1st year PG Scholar 
Affiliation  Amrita School of Ayurveda 
Address  Department of Shalya Tantra, School of Ayurveda, Amrita University, Vallikavu, Clappana P.O, Kollam

Kollam
KERALA
690525
India 
Phone  7012183609  
Fax    
Email  saranyav.nair@gmail.com  
 
Source of Monetary or Material Support  
School of Ayurveda, Amrita University, Vallikavu, Clappana P.O. Kollam-690525 Kerala 
 
Primary Sponsor  
Name  Amrita School of Ayurveda 
Address  School of Ayurveda, Amrita University, Vallikavu, Clappana PO, KOLLAM-690525 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Saranya V Nair  Amrita School of Ayurveda  Department of Shalya Tantra, School of Ayurveda, Amrita University, Vallikavu, Clappana P.O, Kollam
Kollam
KERALA 		 7012183609

saranyav.nair@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Diabetic Foot Ulcer, (1) ICD-10 Condition: L974||Non-pressure chronic ulcer of heeland midfoot,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nimbadi kalka  It is a paste preparation, made from Nimba (Neem leaves), Tila (Sesame seeds), Madhu (Honey) and Sarpi (Ghee).This paste will be applied externally over the wound after cleaning the wound with normal saline for a duration of 45 days. Route of administration:- Externally Dose:-depending upon the wound area Duration- 45 days 
Comparator Agent  Not Applicable  Not Application 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1)Reduction in wound size assessed by wound tracing sheet  45 days 
 
Secondary Outcome  
Outcome  TimePoints 
1)Effect on wound discharge assessed by the soak-age of gauze pad
2)Effect on granulation tissue formation assessed using photo documentation
 		 45 days 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
Final Enrollment numbers achieved (Total)= "15"
Final Enrollment numbers achieved (India)="15" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   01/03/2018 
Date of Study Completion (India) 28/10/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 28/10/2019 
Estimated Duration of Trial   Years="1"
Months="3"
Days="30" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Tripathy, Rabinarayan & Nair, SaranyaV & Lakshman, Vivek & Raj, Shaithya & Otta, SusmitaPriyadarshinee. (2020). Wound-healing potential of Nimbadi Kalka in diabetic foot ulcer: a clinical study. Journal of Indian System of Medicine. 8. 102. 10.4103/JISM.JISM_59_20.  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

The research work entitled “Open Label Clinical Trial to Assess the Efficacy of Nimbadi Kalka in Diabetic Foot Ulcer” was carried out in the OPD and IPD of Amrita School of Ayurveda and Amrita Institute of Medical Science, on 15 patients. They were assessed on the basis of Pain, Granulation tissue formation, Exudate, and reduction in Wound Size on the 15th, 30th, and 45th day. Based on the study following conclusions can be drawn -

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

·       It has been proven beneficial in the reduction of exudate, pain, and wound size. There was 100% relief in pain, 95% reduction in exudate, and 88% in wound size, and after 15 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 to its better availability and safety.

·       No adverse drug reaction (ADR) and side effects were reported during the course of treatment so the drug in the form of paste as the external or topical application is safe.

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

 
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