| CTRI Number |
CTRI/2025/02/081337 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
25/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Study the effect of Truna Taila applied externally and Arogyavardhini vati taken Orally in Vicharchika with special reference to Eczema |
|
Scientific Title of Study
|
Randomised Open Controlled Clinical Trial to Evaluate the Efficacy of Truna Taila for external application along with Arogyavardhini vati orally in Vicharchika w s r to Eczema |
| 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 Abhishek Subhash Raut |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic College and Post Graduate Training and Research Centre Kodoli |
| Address |
OPD No 17 kayachikitsa Department Second Floor
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli
Tal Panhala Dist Kolhapur MAHARASHTRA
416114 India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7875136530 |
| Fax |
|
| Email |
abhishekraut431@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suryakiran Parshuram Wagh |
| Designation |
HOD Kayachikitsa Department |
| Affiliation |
Yashwant Ayurvedic College and Post Graduate Training and Research Centre Kodoli |
| Address |
OPD No 17 kayachikitsa Department Second Floor
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli
Tal Panhala Dist Kolhapur MAHARASHTRA
416114 India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9822846910 |
| Fax |
|
| Email |
suryakiran_wagh@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhishek Subhash Raut |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic College and Post Graduate Training and Research Centre Kodoli |
| Address |
OPD No 17 kayachikitsa Department Second Floor
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli
Tal Panhala Dist Kolhapur MAHARASHTRA
416114 India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7875136530 |
| Fax |
|
| Email |
abhishekraut431@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic College and Post Graduate Training and Research Centre Kodoli Kolhapur Maharashtra 416114 |
|
|
Primary Sponsor
|
| Name |
Dr Abhishek Subhash Raut |
| Address |
OPD No 17 kayachikitsa Department Second Floor
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli
Tal Panhala Dist Kolhapur MAHARASHTRA
416114 India |
| 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 Abhishek Subhash Raut |
Yashwant Dharmartha Rugnalaya |
OPD No 17 kayachikitsa Department Second Floor
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli
Tal Panhala Dist Kolhapur MAHARASHTRA
416114 India
Kolhapur
MAHARASHTRA |
7875136530
abhishekraut431@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Yashwant Ayurvedic College PGT and RC Kodoli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L209||Atopic dermatitis, unspecified. Ayurveda Condition: VICARCIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Arka Taila, Reference: Sharangdhar Samhita , Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Arogyavardhini Vati , Reference: Rasaratna Samuchay , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Koshna Jala ), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Truna Taila , Reference: Vangasena Samhita , Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Arogyavardhini Vati , Reference: Rasaratna Samuchay , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Koshna Jala ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients having symptoms of Vicharchika that is Mandal Atikandu Severe itching Ruja pain Rukshata Dryness skin discolorations strava thickening of
skin
Patient will be selected irrespective of Gender and Occupation
Chronicity less than 1 year acute or newly diagnose |
|
| ExclusionCriteria |
| Details |
Eczema with complications.
Patients suffering known complaints of HIV Asthma
Patients not fulfilling the inclusion criteria
Chronicity more than 1 year |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the efficacy of Truna Taila for external application to
affected area along with Arogyavardhini Vati for 30 days in Vicharchika. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the effect of Truna Taila for external application for Arogyavardhini Vati orally as per mentioned in Ayurvedic Samhita
To study efficacy of Truna taila for external application and Arogyavardhini Vati orally for sign like Shyavata Strava kandu ruja mandal rukshata in 30 days duration
To study Vicharchika chikitsa as per ancient Ayurveda
To study the modern aspect of Eczema |
30 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
10/03/2025 |
| 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
|
This is Randomised Open Controlled Clinical Trial to Evaluate the Efficacy of Truna Taila for external application along with Arogyavardhini Vati orally in vicharchika Assesment of signs and symptoms will be done at regular intervals Observation will be drawn from the outcome of patients after 30 days |