| CTRI Number |
CTRI/2024/11/076375 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
24/10/2024 |
| 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
|
Jatyadi Taila cauterization in the management of corn. |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Study To Evaluate Effect Of Jatyadi Taila Dagdha Agnikarma In The Management Of Kadara (Corn). |
| 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 Dilipkumar Malajibhai Parmar |
| Designation |
PG Scholar |
| Affiliation |
G. J. Patel Institute of Ayurvedic Studies and Research. |
| Address |
Department of Shalya Tantra, OPD No. 25, S. G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India- 388120
Anand
GUJARAT
388120
India |
| Phone |
9998632462 |
| Fax |
|
| Email |
dilipparmar703@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhimant Bhatt |
| Designation |
Associate Professor |
| Affiliation |
G. J. Patel Institute of Ayurvedic Studies and Research. |
| Address |
Department of Shalya Tantra, OPD No. 25, S. G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India- 388120
Anand
GUJARAT
388120
India |
| Phone |
9724967007 |
| Fax |
|
| Email |
dhimant.bhatt@cvmu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhimant Bhatt |
| Designation |
Associate Professor |
| Affiliation |
G. J. Patel Institute of Ayurvedic Studies and Research. |
| Address |
Department of Shalya Tantra, OPD No. 25, S. G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India- 388120
GUJARAT
388120
India |
| Phone |
9724967007 |
| Fax |
|
| Email |
dhimant.bhatt@cvmu.edu.in |
|
|
Source of Monetary or Material Support
|
| S. G. Patel Ayurveda Hospital and Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India- 388120 |
|
|
Primary Sponsor
|
| Name |
Dr Dilipkumar Malajibhai |
| Address |
Department of Shalya Tantra, OPD No. 25, S. G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India- 388120 |
| 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 Dilipkumar Malajibhai Parmar |
S. G. Patel Ayurveda Hospital and Maternity Home |
Department of Shalya Tantra, OPD No. 25, New Vallabh vidyanagar, Anand, Gujarat, India- 388120
Anand
GUJARAT |
9998632462
dilipparmar703@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| G J Patel Institute Of Ayurvedic Studies And Research & S G Patel Ayurveda Hospital & Maternity Home Institutional(Human) Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L84||Corns and callosities. Ayurveda Condition: KADAR, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Jatyadi Taila, Reference: Sharangdhar Samhita madhyam Khanda 9, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Electro cauterization | Frequency: single time until hemostasis is achieved
Route: Local application over the wound. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Participants suffering from minimum 2 or more Kadara lakshan as per classics.
2)Participants aged between 18-60 years.
3)Participants Should be selected irrespective of their gender, caste, religion,and profession.
4)Size of Kadara between 1-2 cm.(Diameter) |
|
| ExclusionCriteria |
| Details |
1)Participants contra-indicated for Agnikarma as per classics.
2)K/C/O Comorbid condition i.e. DM, HTN.
3)Diagnosed cases of HIV, Tuberculosis, Hepatitis.
4)Diagnosed cases of Peripheral vascular disease.
5)Pregnant lady and lactating mother. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Jatyadi Taila Dagdha Agnikarma will have efficacy in the post operative haemorrhage and post-operative pain in Kadara. |
7 DAYS. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Jatyadi Taila Dagdha Agnikarma will have efficacy in the post operative wound healing in Kadara. |
14 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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/11/2024 |
| 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 Yet Recruiting |
| 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
|
In a Randomised Comparative Clinical Study, 30 participants will be selected and equally divided into two groups. Trial Drug Group A Hot snigdh dravya (jatyadi taila) will be applied with gauze piece At excised part of kadara followed by dressing with jatyadi taila and In Control Group B Electro-cauterization will be done at the excised part of kadara followed by dressing with jatyadi taila. Along with in both groups internal medicine Triphala guggulu 2 Tab BID A/F with warm water and Gandhak Rasayan 2 Tab BID A/F with warm water. Follow-up will be taken up to one month or complete healing whichever is less. Assessment will be done with a case record form with criteria like Pain, Burning sensation, haemorrhage, wound healing . Collected data will be analyzed statistically using suitable methods, and a conclusion will be drawn. |