| CTRI Number |
CTRI/2024/06/069002 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
14/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Curative] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical Study to Compare the effect of Panchshirish Agada lepa and Chakramarda Bija lepa in Dadru Kushtha with special reference Tinea infection as local application |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Study to evaluate the efficacy of Panchshirish Agada lepa and Chakramarda Bija Lepa on Dadru Kushtha w.s.r. Tinea Infection |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rachna |
| Designation |
PG Scholar |
| Affiliation |
Institute For Ayurved Studies and Research, Faculty of Ayurved, Kurukshetra |
| Address |
PG Department of Agadtantra, Institute For Ayurved Studies and Research, Shri Krishna Ayush University, Sector-8 Umri Road, Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9050337317 |
| Fax |
|
| Email |
drachna1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rachna |
| Designation |
PG Scholar |
| Affiliation |
Institute For Ayurved Studies and Research, Faculty of Ayurved, Kurukshetra |
| Address |
PG Department of Agadtantra, Institute For Ayurved Studies and Research, Shri Krishna Ayush University, Sector-8 Umri Road, Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9050337317 |
| Fax |
|
| Email |
drachna1997@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rachna |
| Designation |
PG Scholar |
| Affiliation |
Institute For Ayurved Studies and Research, Faculty of Ayurved, Kurukshetra |
| Address |
PG Department of Agadtantra, Institute For Ayurved Studies and Research, Shri Krishna Ayush University, Sector-8 Umri Road, Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9050337317 |
| Fax |
|
| Email |
drachna1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute For Ayurved Studies and Research, Faculty of Ayurved, Shri Krishna AYUSH University,Sector-8 Umri Road, Kurukshetra,
Haryana-136118
India |
|
|
Primary Sponsor
|
| Name |
Institute For Ayurved Studies and Research, Shri Krishna AYUSH University, Kurukshetra |
| Address |
Institute For Ayurved Studies and Research, Shri Krishna AYUSH University, Sector-8 Umri Road, Kurukshetra |
| 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 Brijendra Singh Tomar |
Institute For Ayurved Studies and Research, Shri Krishna AYUSH University, Kurukshetra |
Room no 86,PG Department of Agadtantra, Institute For Ayurved Studies and Research, Faculty of Ayurved, Shri Krishna AYUSH University, Sector-8 Umri Road, Kurukshetra-136118
Kurukshetra
HARYANA |
8950264121
drbs_tomar@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Shri Krishna AYUSH University Kurukshetra. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B354||Tinea corporis. Ayurveda Condition: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Sharangdhar samhita, Procedure details: Desired quantity of Panchshirish agada churna depending on size of lesion will be mix with sufficient amount of lukewarm water and lepa will be prepared. Duration- twice a day for 21 days.)
| | 2 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: Sharangdhar samhita, Procedure details: Desired quantity of Chakramarda bija churna depending on size of lesion will be mix with sufficient amount of lukewarm water and lepa will be prepared. Duration- twice a day for 21 days.)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with signs and symptoms of Dadru
Kushtha.
2.Patients between the age group of 18 years to 60 years. |
|
| ExclusionCriteria |
| Details |
1.Patients below 18 years and above 60 years of age.
2.Chronicity more than 2 years.
3.Known case of diabetes.
4.Dadru Kushtha associated with other skin diseases. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical assessment of Panchshirish Agada lepa and Chakramarda Bija lepa in Dadru Kushtha with special reference Tinea infection as local application. |
3 weeks and follow up on 4 weeks after treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To observe the changes in quality of life in the patients as per relief of symptoms of disease.
2.To collect & analyses literature of Dadru Kushtha from different medical texts of Ayurveda & Modern. |
2 months |
|
|
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 3 |
|
Date of First Enrollment (India)
|
31/07/2024 |
| 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="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
|
Dadru Kushtha is commonly prevalent skin manifestation, it is curable but very resolute in nature even after usage of anti-fungal medications. The purpose of this clinical study to evaluate efficacy of Panchshirish Agad lepa (Interventional Drug) and Chakramarda Bija lepa (Control Drug) on Dadru Kushtha w.s.r. Tinea infection as external application.The study will be conducted in two groups each group comprises 20 patients. The external application of lepa will be twice a day with lukewarm water for 21 days. Follow up will be done after 1 week after completion of treatment. Patients will be selected in each group as per inclusion criteria and exclusion criteria. The assessment of signs and symptoms will be done by Subjective and objective criteria. Informed written consent will be taken before clinical trial. |