| CTRI Number |
CTRI/2024/10/074606 [Registered on: 01/10/2024] Trial Registered Prospectively |
| Last Modified On: |
24/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
An ayurvedic treatment of non healing ulcers with the help of leech therapy, jatyadi taila and shodhan kesari lepa. |
|
Scientific Title of Study
|
Comparative clinical evaluation of jalauka avcharana (leech application) with jatyadi taila and shodhan kesari lepa in “dushta vrana†(non healing wounds). |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VARNIKA GHILDIYAL |
| Designation |
PG SCHOLAR |
| Affiliation |
Uttarakhand Ayurved University Gurukul Campus Haridwar |
| Address |
OPD No 7 Shalya Department, Uttarakhand Ayurved University Gurukul Campus Haridwar, 249402 Uttarakhand INDIA
Hardwar
UTTARANCHAL
249402
India |
| Phone |
8077049921 |
| Fax |
|
| Email |
varnikaghildiyal9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devesh Shukla |
| Designation |
Associate Professor |
| Affiliation |
Uttarakhand Ayurved University Gurukul Campus Haridwar |
| Address |
OPD No 7 Shalya Department, Uttarakhand Ayurved University Gurukul Campus Haridwar.
Hardwar
UTTARANCHAL
249404
India |
| Phone |
9412155386 |
| Fax |
|
| Email |
drdeveshshukla@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Varnika Ghildiyal |
| Designation |
PG Scholar |
| Affiliation |
Uttarakhand Ayurved University Gurukul Campus Haridwar |
| Address |
OPD No 7 Shalya Department, Uttarakhand Ayurved University Gurukul Campus Haridwar
Hardwar
UTTARANCHAL
249404
India |
| Phone |
8077049921 |
| Fax |
|
| Email |
varnikaghildiyal9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gurukul campus, Uttarakhand Ayurved University, Hardwar, 249404, Uttarakhand, India |
|
|
Primary Sponsor
|
| Name |
Varnika Ghildiyal |
| Address |
OPD No. 7 Shalya Department Uttarakhand Ayurved University Gurukul Campus Haridwar |
| 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 |
| Varnika Ghildiyal |
Gurukul Campus, Uttarakhand Ayurved University |
Shalya Department OPD No 7
Hardwar
UTTARANCHAL |
08077049921
varnikaghildiyal9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee Uttarakhand Ayurved University gurukul campus haridwar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:T813||Disruption of wound, not elsewhereclassified. Ayurveda Condition: DUSHTAVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | jalaukAvacaraNam, जलौकावचरणमॠ| (Procedure Reference: Shusruta Samhita, Procedure details: Leech application will be done on the wound site every 8th day followed by application of Shodhan Kesari Lepa. The duration of the study will depend on the size of wound & the maximum duration will be of 90 days.)
(1) Medicine Name: Shodhan Kesari Lepa, Reference: Bhavprakash Samhita, Route: Topical, Dosage Form: Lepa Churna, Dose: 3(g), Frequency: od, Duration: 90 Days | | 2 | Intervention Arm | Procedure | - | jalaukAvacaraNam, जलौकावचरणमॠ| (Procedure Reference: Shusruta Samhita, Procedure details: Leech will be applied on the wound site every 8th day followed by application of jatyadi taila. The duration of therapy will depend on the size & chronicity of the wound & the maximum period would be 90 days.)
(1) Medicine Name: Jatyadi Taila, Reference: Sharangdhar Samhita, Route: Topical, Dosage Form: Taila, Dose: 3(ml), Frequency: od, Duration: 90 Days |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from Dushta Vrana on any part of the body, Non-specific ulcers, Patients with controlled diabetes. |
|
| ExclusionCriteria |
| Details |
Patients with known case of malignancy, malignant ulcers and burns (3rd degree),Specific ulcers (Tubercular ulcers, Syphilitic ulcers), Patients with uncontrolled diabetes, Underlying bony lesions, Patient with bleeding disorders ,HIV, Hepatitis B, Hepatitis C positive patient
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Relief in subjective parameters
1-Pain
2-Tenderness
3-Foul Smell
4-Discharge |
assessment will be done in every 7 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
relief in objective parameters
1-Size
2-Depth
3-Edges
4-Granulation.
|
assessment will be done in every 7 days. |
|
|
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 |
|
Date of First Enrollment (India)
|
15/10/2024 |
| 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
|
The title of the study is "Comparative Clinical Evaluation Of Jalauka avcharana (Leech Application) With Jatyadi Taila And Shodhan Kesari Lepa In “Dushta Vrana†(Non Healing Wounds)". The study focuses on treating the non healing wound by application of jalauka (leeches) on the wound area followed by application of jatyadi taila or shodhan kesari lepa for the purpose of wound healing. The entire duration of the study is 18 months. Assessment of each patient will be done in every 7 days. The result will be recorded. |