| CTRI Number |
CTRI/2023/08/056447 [Registered on: 11/08/2023] Trial Registered Prospectively |
| Last Modified On: |
01/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical trial on Effect of Vikeshika prepared with Malahara using Madhu-Sarpi in management of Dushta Vrana ( infected Wound). |
|
Scientific Title of Study
|
Clinical study on effect of Vikesika prepared with Malahara using Madhu-Sarpi in management of Dushta Vrana. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dhriti Khandelwal |
| Designation |
PG scholar- Department of Shalya Tantra |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Bangalore-Mangalore Highway road, Thanniruhalla, Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9591096541 |
| Fax |
|
| Email |
dhritikhandelwal96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasanna Narasimha Rao |
| Designation |
Principal and Professor - Department of Shalya Tantra |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Bangalore-Mangalore Highway road, Thanniruhalla, Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9448064277 |
| Fax |
|
| Email |
profpnrao@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prasanna Narasimha Rao |
| Designation |
Principal and Professor - Department of Shalya Tantra |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Bangalore-Mangalore Highway road, Thanniruhalla, Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9448064277 |
| Fax |
|
| Email |
profpnrao@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala College of Ayurveda and Hospital, Hassan |
|
|
Primary Sponsor
|
| Name |
Dr Dhriti Khandelwal |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Bangalore-Mangalore Highway road, Thanniruhalla, Hassan- 573201, Karnataka, India |
| Type of Sponsor |
Other [self] |
|
|
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 Dhriti Khandelwal |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan |
Department of Shalya Tantra, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Bangalore-Mangalore Highway road, Thanniruhalla, Hassan-573201
Hassan
KARNATAKA |
9591096541
dhritikhandelwal96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L979||Non-pressure chronic ulcer of unspecified part of lower leg. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | vraNasyaShaShTi-upakramAH, वà¥à¤°à¤£à¤¸à¥à¤¯à¤·à¤·à¥à¤Ÿà¤¿-उपकà¥à¤°à¤®à¤¾à¤ƒ | (Procedure Reference: Sushruta samhita, Procedure details: Under aseptic measures Cleaning of the wound and surrounding with normal saline and sterile gauze. Participants will be placed in a suitable position depending on the site of the lesion. Vikesika prepared with Malahara using Madhu-Sarpi will be placed over the wound sterile gauze pad will be placed over the Vikeshika and bandaged appropriately. The next morning the Vikeshika will be removed. Participants will be applied vikeshika daily till shuddha vrana lakshana are seen or upto 4 weeks.)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects of age group between 18-60 years irrespective of Gender
2.Ulcer which has not been healed within 28 days
3.Ulcer within the size of 7X7 cms |
|
| ExclusionCriteria |
| Details |
Patients who are a Known Case of-
1.Tuberculosis, Uncontrolled Diabetes mellitus with HbA1C > 8 %
2.Malignant ulcers
3.Human Immunodeficiency Virus, Hepatitis B
4.Buerger’s disease
5.Osteomyelitis. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Healthy granulation tissue
Reduction in pain
Reduction in discharge from wound |
At baseline,7th,14th,21st & 28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Burning sensation
Itching
Smell
Size of the wound
|
At baseline,7th,14th,21st & 28th day. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
27/08/2023 |
| 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
|
Discontinuation of skin and its underlying tissues is Vrana, scar of which remains lifelong until death. Longstanding Vrana is known as Dushta Vrana. Dushta Vrana is a common and often encountered problem faced in surgical practice. The presence of DushtaVrana worsens the condition of the patient with different complications and may become fatal. Local factors on wound like slough, infection and foreign body, affect the normal process of healing. Therefore, in the present concept all efforts are directed to keep the wound clean during the various stages of its healing. Good wound healing with minimal scar formation with least pain effectively is the prime motto of every surgeon.
The management of Vrana and Dushta Vrana with the help of 60 Upakrama have been enumerated. Among these, application of Vikeshika has been mentioned for both Vrana Shodhana and Vrana Ropana karma. Lot of references are available on use of Purana madhu & Gritha used as Vrana Shodaka and Vrana Ropaka. Sushruta mentions 13 types of Vrana Bandhana for healing purpose in different forms like Vikeshika, Kavalika, Plota, Pichu,etc. But these techniques are not widely used in clinical practice, hence there is lot of scope for research.
The conventional method of applying Lepa / Kalka / Taila / any other topical applications, though effective yet is quite lengthy and process requiring lot of time and is tedious, also there is lot of drug wastage seen usually with insufficient contact time provided.
Hence, keeping these into consideration, this study is undertaken due to its accessibility and easier application with an intention to explore the effect of Vikesika prepared with Malahara using Madhu-Sarpi in management of Dushta Vrana which will be an innovative contribution in Ayurvedic dressing method. |