| CTRI Number |
CTRI/2024/07/070877 [Registered on: 19/07/2024] Trial Registered Prospectively |
| Last Modified On: |
18/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two drugs, Tilakusumadi Lepa and Sarjarasadi Lepa in the treatment of Palmo Plantar Psoriasis |
|
Scientific Title of Study
|
A Comparative Clinical Study On The Effect of Tilakusumadi Lepa and Sarjarasadi Lepa in the Management of Vipadika Palmo Plantar Psoriasis |
| 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 Tushar Maurya |
| Designation |
PG Scholar |
| Affiliation |
Kunwar Shekhar Vijendra Ayurved Medical College And Research Centre, Shobhit University |
| Address |
Department of Kaya Chikitsa, Adarsh Institutional Area,Babu Vijendra Marg Gangoh,Distt. Saharanpur U.P. India
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
9910570579 |
| Fax |
|
| Email |
tushmaurya25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tushar Maurya |
| Designation |
PG Scholar |
| Affiliation |
Kunwar Shekhar Vijendra Ayurved Medical College And Research Centre, Shobhit University |
| Address |
Department of Kaya Chikitsa, Adarsh Institutional Area,Babu Vijendra Marg Gangoh,Distt. Saharanpur U.P. India
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
9910570579 |
| Fax |
|
| Email |
tushmaurya25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bandana Dhall |
| Designation |
Professor |
| Affiliation |
Kunwar Shekhar Vijendra Ayurved Medical College And Research Centre, Shobhit University |
| Address |
Department of Kaya Chikitsa, Adarsh Institutional Area,Babu Vijendra Marg Gangoh,Distt. Saharanpur U.P. India
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
9348061460 |
| Fax |
|
| Email |
bandanadhall1981@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kunwar Shekhar Vijendra Ayurved Medical College And Research Centre, Shobhit University, Adarsh Institutional Area,Babu Vijendra Marg Gangoh, Distt.Saharanpur U.P. India 247341 |
|
|
Primary Sponsor
|
| Name |
Kunwar Shekhar Vijendra Ayurved Medical College And Research Centre Shobhit University |
| Address |
Adarsh Institutional Area,Babu Vijendra Marg Gangoh,Distt. Saharanpur U.P. India 247341 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Tushar Maurya |
Kunwar Shekhar Vijendra Ayurved Medical College And Research Centre, Shobhit University |
Department of Kaya Chikitsa,
Adarsh Institutional Area,Babu Vijendra Marg Gangoh,Distt. Saharanpur U.P. India 247341
Saharanpur
UTTAR PRADESH |
9910570579
tushmaurya25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kunwar Shekhar Vijendra Ayurved Medical College And Research Centre,Shobhit University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L209||Atopic dermatitis, unspecified. Ayurveda Condition: VIPADIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Tilakusumadi Lepa, Reference: Bhaishajya Ratnavali Chapter 54/39, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 0(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: Thickness-1/4th Angul(Approx 0.5cm thick) | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Sarjarasadi Lepa, Reference: Cakradatta Chikitsa sangraha Chapter 50/42, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 0(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: Thickness-1/4th Angul(Approx 0.5cm thick) |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who fulfill the diagnostic criteria i.e. presenting with classical signs and symptoms of Vipadika.
2. Subjects of age between 18-60 year, irrespective of sex, religion, occupation and economic status will be selected. |
|
| ExclusionCriteria |
| Details |
1. Patients suffering from hemolytic disorder, bleeding disorders, hereditary problems.
2. Patients suffering from any other major systemic disorders like diabetic mellitus, HIV etc.
3. Associated with other forms of skin diseases.
4. Pregnant women and Lactating mothers.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Sign and Symptoms of Vipadika |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Cost Effective Treatment
2.To observe adverse effects if any. |
45 Days |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
15/08/2024 |
| 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 volunteers will be informed about the study protocol. Willing Participants will be randomly selected as per Computer generated table. The clinical research format will be prepared and validated. Prior to the study approval will be taken from IEC, KSVAMC & RC,SU GANGOH, SAHARANPUR and CTRI registration will be done. after selection, each participant will be tested individually and selected according to the selection criteria. They are divided into two groups a trial is a parallel-group, randomized, open label trial. it will include 45 days treatment period and an every 15th day follow-up period. |