| CTRI Number |
CTRI/2022/07/043745 [Registered on: 06/07/2022] Trial Registered Prospectively |
| Last Modified On: |
02/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [local application] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Healing of chronic wounds by using Katphala Kshar- Plota and Nirgundi oil locally |
|
Scientific Title of Study
|
Comparative evaluation on effect of Katphala Kshar - Plota and Nirgundi Taila in Dushta - Varna |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ajay Kumar Gupta |
| Designation |
Professor |
| Affiliation |
Rishikul Campus, Haridwar, Uttarakhand Ayurved University |
| Address |
OPD No. 7, Department of Shalya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University
Hardwar
UTTARANCHAL
249201
India |
| Phone |
9412856414 |
| Fax |
|
| Email |
akg1409@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Kumar Gupta |
| Designation |
Professor |
| Affiliation |
Rishikul Campus, Haridwar, Uttarakhand Ayurved University |
| Address |
OPD No. 7, Department of Shalya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University
UTTARANCHAL
249201
India |
| Phone |
9412856414 |
| Fax |
|
| Email |
akg1409@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suman Kohali |
| Designation |
P G Scholar |
| Affiliation |
Rishikul Campus, Haridwar, Uttarakhand Ayurved University |
| Address |
OPD No. 7, Department of Shalya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University
Hardwar
UTTARANCHAL
249201
India |
| Phone |
8126337618 |
| Fax |
|
| Email |
Sumankantikohali26@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD No.7, Department of Shalya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University |
|
|
Primary Sponsor
|
| Name |
Uttarakhand Ayurved University |
| Address |
Uttarakhand Ayurved University, Harrawala, Dehradun
|
| Type of Sponsor |
Government 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 Suman kohali |
Rishikul Campus, Haridwar |
OPD and IPD No. 7, Department of Shalya Tantra, Rishikul Campus, Haridwar, Uttarakhan
Ayurved University
Hardwar
UTTARANCHAL |
8126337618
Sumankantikohali26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Uttarakhand Ayurved University, Rishikul Campus, Haridwar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Nirgundi Taila, Reference: Bhaisjya Ratnawli, Nadi Vrana Chiktsa 50/26-27, Route: Topical, Dosage Form: Taila, Dose: 0(NA), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 6 Months, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Katphala Kshar-plota, Reference: Sushruta Sutra 38/64, Route: Topical, Dosage Form: Kshara , Dose: 0(NA), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 6 Months, anupAna/sahapAna: No, Additional Information: dose will be decided as per size of wound |
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient suffering from Dushta-Vrana on any part of the body.
2. All age groups patients.
3. Non specific ulcers.
4. Post operative infected wounds.
|
|
| ExclusionCriteria |
| Details |
1. Patient with evidence of malignancy and malignant ulcers.
2. Tubercular ulcers.
3. Syphilitic ulcers.
3. Underlying bony lesions.
4. Patient with bleeding disorders.
5. HIV,Hepatitis B, Hepatitis C positive patient. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Healing in Chronic Wounds will be assessed based on following parameters -
1. Improvement in Tenderness
2. Reduction in Foul Smell
3. Floor/Granulation
4. Reduction in Size
5. Decrease in amount of Discharge
6. Relief in Intensity of Itching
7. Decrease in intensity of Pain |
It be assessed every 15th Day for 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Healing of wound |
It be assessed every 15th Day for 6 months |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
09/07/2022 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Healing of Vrana is a physiological process of regeneration and repair after injury. Due to interference of
vitiated Doshas, Vrana becomes Dushta and normal healing gets delayed. Dushta -Vrana can be considered
as Chronic Non-Healing ulcer like venous ulcer, diabetic ulcer, arterial ulcer, infected ulcer. The presence
of Dushta-Vrana worsens the condition of the patient to a greater extent. Dushta- Vrana being a chronic
ailment causes long term suffering and which may even become fatal.Kshar is non-invasive procedure without major complications, does the Shodhana of Dushta Vrana, remove
all slough/dead tissue and Vrana becomes Shuddha and thus enhances wound healing. Acharya Sushruta
also defines the Kshara, the substance processing Ksharana (melting away) and Kshanana (destroying the
lesion) properties. Acharya Sushruta has given number of Vrana-bandhan dravya viz., Pichu, Plota, Kawalika and
Vikeshika. He advocated numerous herbal drugs for local application as well as systemic use. Katphala, Daruharidra
and Nirgundi are the plants mentioned specially for Dushta-Vrana by Acharya Sushruta. So, Katphala Kshar-plota and Nirgundi Taila for Shodhana and Ropana of Dushta-Vrana by local
application is a good alternative. |