| CTRI Number |
CTRI/2024/07/070433 [Registered on: 10/07/2024] Trial Registered Prospectively |
| Last Modified On: |
09/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Para Surgical] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Thermal Cauterization And Aragwadha Pratisarneeya Kshar on WARTS |
|
Scientific Title of Study
|
A clinical Study To Evaluate The Efficacy Of Thermal Cauterization And Aragwadha Pratisarneeya Kshara In The Management Of Charmakeela Wsr To Common Warts |
| 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 Nilesh Kumar Ramjeebhai |
| Designation |
Pg scholar Shalya Tantra |
| Affiliation |
MMM Government Ayurved College Udaipur Rajsthan |
| Address |
Department Of Shalya Tantra MMM Government Ayurved College Udaipur Rajsthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9714869072 |
| Fax |
|
| Email |
nileshdhameliya212@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Mahesh Dixit |
| Designation |
Head Of Department Of Shalya Tantra |
| Affiliation |
MMM Government Ayurved College Udaipur Rajsthan |
| Address |
Department Of Shalya Tantra MMM Goverment Ayurveda College Udaipur Rajsthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9414245459 |
| Fax |
|
| Email |
prof.maheshdixit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Mahesh Dixit |
| Designation |
Head Of Department Of Shalya Tantra |
| Affiliation |
MMM Government Ayurved College Udaipur Rajsthan |
| Address |
Department Of Shalya Tantra MMM Goverment Ayurveda College Udaipur Rajsthan
RAJASTHAN
313001
India |
| Phone |
9414245459 |
| Fax |
|
| Email |
prof.maheshdixit@gmail.com |
|
|
Source of Monetary or Material Support
|
| MMM Government Ayurved College Udaipur Rajsthan 313001 |
|
|
Primary Sponsor
|
| Name |
MMM Government Ayurved College Udaipur Rajsthan |
| Address |
MMM Government Ayurved College Udaipur Rajsthan 313001 |
| 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 Nilesh Kumar Ramjeebhai |
MMM Government Ayurved College Udaipur Rajasthan |
OPD 1 & 8 PG Department Of Shalya Tantra associated Group Of Hospitals MMM Government Ayurved College Udaipur Rajasthan
Udaipur
RAJASTHAN |
9714869072
nileshdhameliya212@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan |
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: CARMAKILAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: SUSHRUTA, Procedure details: 1 SITIING PER DAY)
| | 2 | Comparator Arm | Procedure | - | kShArakarma, कà¥à¤·à¤¾à¤°à¤•à¤°à¥à¤® | (Procedure Reference: SUSHRUTA, Procedure details: 1 SITTING PER DAY)
(1) Medicine Name: ARGWADHA PRATISARNEEYA KSHARA, Reference: SUSHRUTA, Route: Topical, Dosage Form: Kshara, Dose: 2(mg), Frequency: od, Duration: 1 Days |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient having sign and symptom of Charmakeela (Common warts).
Patients who are agree for written consent.
Age between 16 to 60 years.
Thermal cauterization and Pratisaraneeya Kshara Yogya patients as per classics |
|
| ExclusionCriteria |
| Details |
Patients who are not agree for written consent.
Non cooperative patients.
Genital warts, flat warts, filiform warts, Mosaic warts.
Any malignancy.
Uncontrolled hypertension and diabetes mellitus.
Other diseases like, severe anaemia, HBsAg, HIV, Immunodeficiency syndrome, Autoimmune disease etc.
Patient who taking blood thinner medicine.
Patients below 16 years and above 60 years.
Pregnancy.
Heart disease such as MI, IHD, CCF.
Thermal cauterization and Pratisaraneeya Kshara Ayogya patients as per classics |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Improvement Of Sign & Symptom Of Warts
2)Reduction Of Hardness,
Roughness & Pigmentation |
1 Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| assesment Of Scar |
28 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
|
Phase 2 |
|
Date of First Enrollment (India)
|
31/10/2024 |
| 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="0"
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
|
THIS STUDY IS A CLINICAL STUDY TO EVALUATE THE EFFICACY OF THERMAL CAUTERIZATION AND ARAGWADHA PRATISARNEEYA KSHARA IN THE MANAGEMENT OF THE CHARMAKEELA W.S.R. TO COMMON WARTS.THERE WILL BE 2 GROUP IN THE STUDY ,IN GROUP A RANDOMLY SELECTED AND CLINICALLY DIAGNOSED 30 PATIENT OF CHARMAKEELA(COMMON WARTS).GROUP A WILL BE GIVEN INTERVENTION BY THERMAL CUATERIZATION ,AND 30 PATIENTOF GROUP B RANDOMLY SELECTED AND CLINICALY DDIAGNOSE WILL BE APPLY THERMAL CAUTERIZATION FOLLOWED BY ARGWADHA PRATISARANEEYA KSHAR.TRIAL WILL BE CONDUCTED FOR A PERIOD OF 2 MONTH .FOLLOW UP OF THE CASE WILL BE DONE AFTER COMPLETION OF 2 MONTHS COURSE ON THE BASIS OF PRIMARY AND SECONDARY OUTCOMES.
THE DATA WILL BE ANALYZED SCIENTIFICALLY AND STATISCALLY. |