| CTRI Number |
CTRI/2025/03/082903 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Other (Specify) [Lepa Chikitsa Topical Application] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Treatment of Non Healing Ulcer with Medicated Topical Application. |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Study to Evaluate the Shodhana effect of Tilaabhayadhi Lepa and Nimbadi Kalka Lepa in the management of Dushta Vrana with special reference to Non healing ulcer |
| Trial Acronym |
TNLNU |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K H M Bharathesh |
| Designation |
Post Graduate |
| Affiliation |
BVVS Ayurved Medical College and Hospital Bagalkot |
| Address |
Department of PG Studies in Shalya Tantra BVVS Ayurved Medical College and Hospital Bagalkot BVVS Ayurved Medical College and Hospital Bagalkot Bagalkot KARNATAKA 587101 India |
| Phone |
8970582664 |
| Fax |
|
| Email |
khmbthejas@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Yogesh S Kulkarni |
| Designation |
Professor and HOD |
| Affiliation |
BVVS Ayurved Medical College and Hospital Bagalkot |
| Address |
Department of PG Studies in Shalya Tantra BVVS Ayurved Medical College and Hospital Bagalkot BVVS Ayurved Medical College and Hospital Bagalkot Bagalkot KARNATAKA 587101 India |
| Phone |
9886664541 |
| Fax |
|
| Email |
dryogesh6@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Mallikarjun S Hiremath |
| Designation |
Professor and Incharge Principal |
| Affiliation |
BVVS Ayurved Medical College and Hospital Bagalkot |
| Address |
Department of Rachana Shareera BVVS Ayurved Medical College and Hospital Bagalkot BVVS Ayurved Medical College and Hospital Bagalkot Bagalkot KARNATAKA 587101 India |
| Phone |
9482631399 |
| Fax |
|
| Email |
malikdost4u@gmail.com |
|
|
Source of Monetary or Material Support
|
| BVVS Ayurved Medical College and Hospital Bagalkot 587101 |
|
|
Primary Sponsor
|
| Name |
Dr K H M Bharathesh |
| Address |
BVVS Ayurved Medical College and Hospital Bagalkot 287101 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr K H M Bharathesh |
BVVS Ayurved Medical College and Hospital Bagalkot 587101 |
Shalya Tantra OPD Room No.03 BVVS Ayurved Medical College and Hospital Bagalkot Bagalkot KARNATAKA |
8970582664
khmbthejas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BVVS Ayurved Medical College and Hospital Bagalkot Karnataka |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L984||Non-pressure chronic ulcer of skin, not elsewhere classified. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Sushruta samhita, Procedure details: The prepared Kalka will be applied on the affected part uniformly according to the size of Dusta Vrana.) (1) Medicine Name: Tilaabhayadi Lepa, Reference: Chakradatta , Route: Topical, Dosage Form: Kalka/ Paste, Dose: 00(NA), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: Sushruta samhita , Procedure details: The prepared Kalka will be applied on the affected part uniformly according to the size of Dusta Vrana) (1) Medicine Name: Nimbadi kalaka Lepa, Reference: Sushruta Samhita Chikitsasthana, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 00(NA), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from Dushta vrana in the age group between 18-70 years and irrespective of gender.
Patients of Nonspecific ulcers of Traumatic ulcer, Arterial ulcer, Venous ulcer, Trophic ulcer, Infective ulcer, Diabetic ulcer and other.
|
|
| ExclusionCriteria |
| Details |
Patients of non healing ulcer with Malignant and Gangrenous changes.
Patients with ulcer of Syphilitic ulcer, Tuberculosis ulcer, Marjolin ulcer, Bedsore ulcer and Leprosy.
Patients of uncontrolled diabetes mellitus.
RVD and HBsAg positive patients.
Pregnant and Lactating women.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in Pain(Vedana)
Reduction in Odour(Gandha)
Reduction in Itching(Kandu) |
At the duration of 7days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in Discharge(Srava) |
At the duration of 7days |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Acharya Sushruta defined Vrana as Gatra Vichoornana, which causes destruction and discoloration of body tissue.1 Dushta Vrana Lakshanas are Krishna, Rakta, Peeta, Shukla Varna, Putimamsa, Puyasrava, Atyartavedana, Dushtashonitasrava, Daha, Paka, Raga, Kandu, Shopha and Dheerghakaleena2. Dushta Vrana can be correlated to non healing ulcer in allied science. Ulcer is a break in the continuity of the covering epithelium, either skin or mucous membrane due to molecular death. Non healing ulcers are characterized by pain, discharge, itching, burning sensation and foul smell. Non healing ulcers include nonspecific ulcers like Traumatic ulcer, Arterial ulcer, Venous ulcer, Trophic ulcer, Infective ulcer, Diabetic ulcer and other.3 An ulcer is a major health problem and it affects nearly 6 million population worldwide. In India it is reported as 4.5 per 1000 population, the incidence of chronic ulcers is expected to increase as the population age increase.4 In modern science ulcer is managed by debridement, ulcer cleaning and dressing. Desloughing is done either mechanically or chemically. Mechanically by debridement. Hydrogen peroxide which releases nascent oxygen is used as chemical agent. Ulcer cleaning and dressing is done daily or twice daily or once in 2-3 days depending on the type of ulcer and type of dressing used.3 Acharya Sushruta has told various Shodana measures like Sharirika Shodana by Vamana, Virechana and Sthanika Shodana by Kashaya, Kalka, and Avachurana, etc. Lepa karma is one among Shashtiupakrama in which drugs of herbal, herbo-mineral or animal origin are used for Vrana Lepana. Lepa karma is an integral part of Shashtiupakrama which ensures the protection against the microbes and it act as Vranashodana by reducing Vedana and Srava.5 Acharya Chakradatta in the context of Bhagandara Chikitsa explained Tilaabhayadi lepa for Bhagandara and Dushtavrana. It contains drugs like Tila, Abhaya, Lodra, Nimba, Haridra, Daruharidra, Vacha, Kusta, Gruhadooma which possess Shodhana properties.6 Acharya Sushruta has mentioned about Nimbadi kalka lepa under Dvivruniya Chikitsa for the Vrana Shodhana which contains drugs like Nimba, Tila and Madhu.7 Here an attempt is made to evaluate and compare the Shodhana effect of Tilaabhayadi Lepa and Nimbadi kalka Lepa in Dushtavrana with special reference to Non healing ulcer. |