| CTRI Number |
CTRI/2023/08/057025 [Registered on: 29/08/2023] Trial Registered Prospectively |
| Last Modified On: |
25/08/2023 |
| 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
|
To evaluate safety and efficacy of Aragwadhpatra Taila in Dadrukushtha(Tinea Corporis) |
|
Scientific Title of Study
|
Randomized controlled clinical trial to evaluate efficacy of Aragwadhpatra Taila versus Chakramarda Taila in Dadrukushtha with special reference to Tinea Corporis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sakina Maziburrahaman Khan |
| Designation |
Post Graduate Student |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate Research Center Ashta |
| Address |
Department of Kayachikitsa Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate Research Center Ashta Tal Walwa Dist Sangli Pin code 416301
Sangli
MAHARASHTRA
416301
India |
| Phone |
9503238769 |
| Fax |
|
| Email |
sakinakhan78692@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rupali Ramadas Patil |
| Designation |
Assistant Professor Department of Kayachikitsa |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate Research Center Ashta |
| Address |
Department of Kayachikitsa Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate Research Center Ashta Tal Walwa Dist Sangli Pin code 416301
Sangli
MAHARASHTRA
416301
India |
| Phone |
9225633321 |
| Fax |
|
| Email |
rupalipatil@adamc.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Rupali Ramadas Patil |
| Designation |
Assistant Professor Department of Kayachikitsa |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate Research Center Ashta |
| Address |
Department of Kayachikitsa Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate Research Center Ashta Tal Walwa Dist Sangli Pin code 416301
Sangli
MAHARASHTRA
416301
India |
| Phone |
9225633321 |
| Fax |
|
| Email |
rupalipatil@adamc.ac.in |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate Research Center Ashta |
|
|
Primary Sponsor
|
| Name |
Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate Research Center Ashta |
| Address |
Department of Kayachikitsa Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate Research Center Ashta Tal Walwa Dist Sangli Pin code 416301 |
| Type of Sponsor |
Private 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 |
| Sakina Maziburrahaman Khan |
Hon Shri Annasaheb Dange Ayurved Medical College and Post Graduate Research Center Ashta |
Department of Kayachikitsa OPD/IPD
Sangli
MAHARASHTRA |
9503238769
sakinakhan78692@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate Research Center Ashta |
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 | Drug | Classical | | (1) Medicine Name: Aragwadhpatra Taila, Reference: Gadanigraha, Bhaisajyaratnavali, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Chakramarda Taila, Reference: Dhanvantarinighantu, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age Group between 16 to 60 years.
2.Patients having area of skin involvement less than
50%.
3.Patient having chronicity less than 1 year. |
|
| ExclusionCriteria |
| Details |
1.Pregnant women and lactating women.
2.Patients having severe systemic disorders. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Signs & Symptoms of disease like kandu, raga, pidika, mandala after 21 days |
7th,14th,21st Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Dermatology Life Quality Index(DLQI) |
7th,14th,21st Day |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
10/09/2023 |
| 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
|
Skin conditions pose a significant threat to the person’s well-being, mental health, ability to function, and social participation. In recent years, there has been a considerable increase in the incidence of skin problems in India due to changing lifestyles and food habits. Dadru is one of the most common skin diseases affecting all the ages of population. It is presented with symptoms like Raga(skin discoloration), Pidaka (skin eruptions), Kandu (itching at the site of the lesion), and Mandala udgama (elevated circular lesion). Many formulations are mentioned in Ayurveda classics for the treatment of Dadru. Here, a study will be done to evaluate the efficacy of Aragwadhpatra Taila in the management of Dadrukushtha. Aragwadhpatra lepa along with kanji is described in granthas for the treatment of Dadrukushta. Aragwadhpatra taila will be prepared by using sharshap taila as base. The drug Aragwadh have kushthghna property. Sharshap taila have katu rasa, ushna virya and katu vipaka and is vata-kapha shamak in nature.It also has kandughna property. Hence to obtain best and beneficial outcome study trial of Aragwadhpatra Taila has been planned to carry. Study time - 21 days Follow up- on 7th 14th and 21st day Drug dose- For local application as per requirement Study duration- 1 year 6 months |