| CTRI Number |
CTRI/2025/03/083073 [Registered on: 21/03/2025] Trial Registered Prospectively |
| Last Modified On: |
30/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Preventive
Other (Specify) [Curative] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the efficacy of shoth shardula taila and jatyadi taila application with jalaukavachrana on dushta vrana(putrified wound) |
|
Scientific Title of Study
|
A Comparative Clinical Study On Efficacy Of Shotha Shardula Taila And Jatyadi Taila Application With Jalaukavacharan On Dushta Vrana (Putrified 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 |
Madhu |
| Designation |
Ms Shalya Tantra |
| Affiliation |
Institute for Ayurveda studies and research,sector 8 ,umri road, kurukshetra |
| Address |
PG department of shalya tantra, institute for Ayurveda studies and research , sector 8 umri road, kurukshetra.
Kurukshetra
HARYANA
136118
India |
| Phone |
9599736233 |
| Fax |
|
| Email |
madhugadad01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Madhu |
| Designation |
Ms Shalya Tantra |
| Affiliation |
Institute for Ayurveda studies and research,sector 8 ,umri road, kurukshetra |
| Address |
PG department of shalya tantra, institute for Ayurveda studies and research , sector 8 umri road, kurukshetra.
Kurukshetra
HARYANA
136118
India |
| Phone |
9599736233 |
| Fax |
|
| Email |
madhugadad01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Madhu |
| Designation |
Ms Shalya Tantra |
| Affiliation |
Institute for Ayurveda studies and research,sector 8 ,umri road, kurukshetra |
| Address |
PG department of shalya tantra, institute for Ayurveda studies and research , sector 8 umri road, kurukshetra.
Kurukshetra
HARYANA
136118
India |
| Phone |
9599736233 |
| Fax |
|
| Email |
madhugadad01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurveda studies and research,shri krishna ayush university, sector 8 umri road, kurukshetra ,Haryana 136118 |
|
|
Primary Sponsor
|
| Name |
Institute for Ayurved studies and research |
| Address |
Institute For Ayurved Studies And Research , Shri Krishna Ayush University ,Sector-8 ,Umri road , Kurukshetra,136118, Haryana |
| 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 Rajender Singh |
Institute for Ayurveda studies and research,shri krishna ayush university |
Room no.104,PG department of shalya tantra,shri krishna ayush university, sector 8 umri road, kurukshetra.
Kurukshetra
HARYANA |
9416662761
drrajendersingh1346@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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: Jatyadi Tailam, Reference: sharangadhar Samhita Madhyama Khanda, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: Will be given with Jaloukavacharana | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shothshardul Tailam, Reference: Bhaishajya Ratnavali, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: Will be given with Jaloukavacharana |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient of both sex.
Patient in age group of 20-70 years.
Patient having symptom of putrified wound .
Patient having normal range of BT,CT,TLC ,DLC count. |
|
| ExclusionCriteria |
| Details |
Patient suffering from chronic disease like tuberculosis, chronic osteomyelitis,known case of malignant ulcer
Gangrenous ulcer, uncontrolled hypertension,ischemic heart disease, uncontrolled diabetic mellitus,diabetic foot ulcer
Patient suffering from specific condition like HIV ,Hbsag ,VDRL ,HCV will be excluded |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the efficacy of shotha shardula taila in comparison to jatyadi taila with jalaokavachrana in dushta vrana (putrified wound). |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in dusta vrana (putrified wound ), better the quality of life of patient |
21 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
Modification(s)
|
Phase 2 |
|
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="0"
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 discontinuity or break in the surface epithelium. A wound is simple when only skin involved. It is complexed when it involves underlined nerves, vessles and tendonds in which the stage of wound healing is delayed that wound is called as chronic wound. In sushruta samhita there is descriptions about wound and its management under vrana adhyaya. Chronic wound comes under dhusta vrana. In sushruta samhita classical features of different vrana are mentioned on the basis of shape, size, smell, pain, colur, discharge like suddha vrana, rohita vrana, samyak and rudha vrana. Vrana which has foul smell, intense pain, take long time to heal and profuse pus discharge of abnormal colour with blood is a dushta vrana. Similar diseases is parallel in contemopary system iof medicine is putrified wound (chronic infected wound). chronic putrified wound are difficult to treat and take more time to heal. To manage these difficulties jalaukavcharana (leech therapy) and for the better healing shotha shardula taila which is mentioned in bhaishajya ratnavali can become effective and easliy available to standard jatyadi taila applicaltion.
|