| CTRI Number |
CTRI/2024/10/074694 [Registered on: 03/10/2024] Trial Registered Prospectively |
| Last Modified On: |
30/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical study to evaluate the efficacy of Ingudi taila over Jatyadi taila in management of Dushta vrana (Chronic wound) |
|
Scientific Title of Study
|
A controlled clinical study to evaluate the efficiency of Ingudi taila over Jatyadi taila in management of Dushta vrana (Chronic wound) |
| 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 Anusha K |
| Designation |
PG Scholar- Department Of Shalya Tantra |
| Affiliation |
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, Koppal |
| Address |
Department of Post Graduate Studies In Shalya Tantra
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital
Koppal
KARNATAKA
583231
India
Koppal
KARNATAKA
583231
India |
| Phone |
9900960414 |
| Fax |
|
| Email |
anushakumar333@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geetanjali Hiremath |
| Designation |
Associate Professor, Department Of Shalya Tantra |
| Affiliation |
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, Koppal |
| Address |
Department of Post Graduate Studies In Shalya Tantra
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital
Koppal
KARNATAKA
583231
India
Koppal
KARNATAKA
583231
India |
| Phone |
7760346752 |
| Fax |
|
| Email |
sanjalihiremath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geetanjali Hiremath |
| Designation |
Associate Professor, Department Of Shalya Tantra |
| Affiliation |
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, Koppal |
| Address |
Department of Post Graduate Studies In Shalya Tantra
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital
Koppal
KARNATAKA
583231
India
Koppal
KARNATAKA
583231
India |
| Phone |
7760346752 |
| Fax |
|
| Email |
sanjalihiremath@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shee Jagadguru Gavisiddeshwara Ayurvedic Medical College, Koppal |
|
|
Primary Sponsor
|
| Name |
Dr Anusha K |
| Address |
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, Gavimath campus, Koppal, Karnataka, 583231 |
| Type of Sponsor |
Other [Self Sponsoring] |
|
|
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 Anusha K |
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, Koppal, Karnataka |
Department of Shalya Tantra OPD No 16,
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College, Gavimata campus, Koppal, Karnataka
Koppal
KARNATAKA |
9900960414
anushakumar333@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College and Hospital, Institutional Ethics Committee |
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 | Drug | Classical | | (1) Medicine Name: Ingudi taila , Reference: Sushruta Samhita, Chikitsa sthana, 31st chapter, 5th Shloka , Route: Topical, Dosage Form: Taila, Dose: 2(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: After Distill water wash, Dushta vrana will be subjected to Ingudi taila local
application under strict aseptic precaution. | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Jatyadi taila, Reference: Bhaisajya Ratnavali, Chapter No. 47, Route: Topical, Dosage Form: Taila, Dose: 2(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: After Distill water wash, Dushta vrana will be subjected to Jatyadi taila local application under strict aseptic precaution. |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient of age Group between 18-60 years, either of gender and having clinical features of Dushta vrana like Vedanayukta [Pain], Deergakalanubandi [chronic], Sravayukta [discharge] and dushta vrana having size less than 6x6cm [l x b] and 2cm depth. |
|
| ExclusionCriteria |
| Details |
Patients with HIV Positive, HBsAg Positive, known case of Tuberculosis, Uncontrolled Diabetes Mellitus, Malignant ulcers and Burns. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of Objective parameter-
Pain,
Discharge |
3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of-
Size,
Depth of the cavity,
Granulation tissue |
TOTAL STUDY DURATION PER PATIENT- 21 Days.
TREATMENT DURATION- 15 Days.
FOLLOW UP PERIOD- on 21st day.
ASSESSMENT DONE ON- 1st day (Before treatment),
3rd day [During treatment],
7th day [During treatment],
15th day [After treatment] and
21st day [During follow up]. |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/09/2027 |
| 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="0"
Months="8"
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
|
A wound is a break in the integrity of the skin or tissue often, which may be associated with disruption of the structure and function . Wounds can be classified as Acute and Chronic wounds. Chronic wounds are defined as wounds that have failed to proceed through the orderly process that produces satisfactory anatomic and functional integrity. Proper wound healing is required to re-establish disturbed anatomic continuity and functional status of the skin. Inappropriate and inadequate treatment of Acute wound is the commonest cause of chronic wound. So if the wound is not managed properly, it may result in a local and systemic infection that leads to septicemia. Later the tissue necrosis leads to gangrene which necessitates further amputation . Treatment of wound was probably the most common medical problem faced by human beings. The frequency of injuries was more common than any other disease. The prevalence rate of chronic wound in the community was reported as 4.5% per 1000 population. Few common management of wound are Debridement, cleaning wound and dressing. De-sloughing is done by mechanically or chemically. According to estimation from the World Health Organization, 80% of the world’s population relies on traditional medicines for their primary healthcare. In Ayurvedic context, wound can be correlated to vrana and Chronic wound to Dushta vrana on the basis of Dushta vrana lakshana expained by Acharya Sushruta. The word Vrana denotes Vrana Gatra Vichurnane which means the tissue disruption. Healing of wounds is one of the important areas of clinical medicine described in many Ayurvedic texts under the heading Vrana ropana. Although vrana shodhaka and ropanaka drugs are described in detail in Ayurvedic Samhitas, a systematic treatment of these concepts may be found in Sushruta Samhita under the heading of Shashti upakrama, of which taila upakrama is one among them. Various drugs has been mentioned for Dushta vrana, out of them Ingudi is specifically selected for its Tikta, kashaya rasa, Kapha Vatahara action, and for treatment of chronicity of wound due to its specific property i.e., Krimigna prabhava. Acharya Sushruta has mentioned Ingudi taila for Dushta vrana which is inexpensive, easily available and minimal drugs used. On the other hand Jatyadi taila which is commonly used for Dushta vrana and its efficacy has proven to be effective. Hence an attempt is made to evaluate the efficacy of Ingudi taila with Jatyadi taila in management of Dushta vrana (Chronic wound).
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