| CTRI Number |
CTRI/2025/06/088313 [Registered on: 05/06/2025] Trial Registered Prospectively |
| Last Modified On: |
04/06/2025 |
| 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 study the effectiveness of Amritarishtadi kashay in vicharchika |
|
Scientific Title of Study
|
RANDOMISED CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY OF AMRITARISHTADI KASHAY IN VICHARCHIKA w.s.r. 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 |
DrSneha Babasaheb Kale |
| Designation |
PG Scholar |
| Affiliation |
CSMSS Ayurved Mahavidyalaya and Rugnalaya, kanchanwadi Aurangabad Maharashtra India pin 431011 |
| Address |
OPD no. 13 , kayachikitsa department,
CSMSS Ayurved Mahavidyalaya and Rugnalaya,kanchanwadi, Aurangabad Aurangabad Maharashtra India 431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
09359120582 |
| Fax |
|
| Email |
snehakale9146@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naresh Ramrao Nimbalkar |
| Designation |
Associate professor |
| Affiliation |
CSMSS Ayurved Mahavidyalaya and Rugnalaya,kanchanwadi,Aurangabad Maharashtra India 431011 |
| Address |
OPD no. 13 ,kayachikitsa department,
CSMSS Ayurved Mahavidyalaya and Rugnalaya,kanchanwadi, Aurangabad Aurangabad Maharashtra India 431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9422711098 |
| Fax |
|
| Email |
ayushakti009@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSneha Babasaheb Kale |
| Designation |
PG Scholar |
| Affiliation |
CSMSS Ayurved Mahavidyalaya and Rugnalaya, kanchanwadi, Aurangabad, Maharashtra India pin 431011 |
| Address |
OPD no. 13 ,kayachikitsa department,
CSMSS Ayurved Mahavidyalaya and Rugnalaya,kanchanwadi, Aurangabad Aurangabad Maharashtra India 431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
09359120582 |
| Fax |
|
| Email |
snehakale9146@gmail.com |
|
|
Source of Monetary or Material Support
|
| CSMSS Ayurved Mahavidyalaya and Rugnalaya kanchanwadi Aurangabad, Aurangabad, Maharashtra India pin 431011 |
|
|
Primary Sponsor
|
| Name |
CSMSS Ayurved Mahavidyalaya and Rugnalaya kanchanwadi Aurangabad Maharashtra India pin |
| Address |
CSMSS Ayurved Mahavidyalaya and Rugnalaya, kanchanwadi Aurangabad Maharashtra, India pin 431011 |
| 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 |
| Dr Sneha kale |
Csmss Ayurved Mahavidyalaya and Rugnalaya , Kamchanwadi Aurangabad Maharashtra |
OPD no. 13, kayachikitsa department, CSMSS Ayurved Mahavidyalaya and Rugnalaya Kamchanwadi,Aurangabad Maharashtra India pin 431011
Aurangabad
MAHARASHTRA |
09359120582
snehakale9146@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC CSMSS Ayurved Mahavidyalaya and Rugnalaya, Aurangabad. |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Amritarishtadi kashay, Reference: Sahasrayog, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -honey), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Patolkaturohinyadi kashay, Reference: Ashatnghridayam, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) patient willing for the treatment.
2) patient of age group 18-60 yrs will be included irrespective of gender,caste,religion,socioeconomic status.
3) patients showing pratyatama lakshanas of vicharchika will be included |
|
| ExclusionCriteria |
| Details |
Patients Having symptoms of vicharchika for more than 1 yr.
Patients Having any other skin disease.
Pt having systemic illness like DM,HTN,IHD etc. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Kandu(itching), vaivarnya(erythema), pidika(papulation), srava(oozing),raji(lichenification), rukshata(dryness) will be decreased |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pruritus and sleep loss will be decreased |
21 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
N/A |
|
Date of First Enrollment (India)
|
18/06/2025 |
| 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 Yet Recruiting |
| 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
|
Vicharchika is a skin disease with symptoms like kandu, srava, rukshata, vaivarnya, pidika, raji etc. In this study total 80 patients of Vicharchika will be taken. Written consent will be taken . Initial assessment will be taken . Furthe patient will be treated with trial and comparative drugs i.e. Amritarishtadi kashay and patolkaturohinyadi kashay resp. Follow up will be taken. Observation and result will be noted. Conclusion and discussion will be done.
Hypothesis Null hypothesis: Amritarishtadi kasha is not effective in Vicharchika w.s.r. to eczema
Alternative hypothesis: Amritarishtadi kashay is not effective in Vicharchika w.s.r. to eczema. |