| CTRI Number |
CTRI/2026/03/105375 [Registered on: 05/03/2026] Trial Registered Prospectively |
| Last Modified On: |
05/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A randomized controlled clinical trial to evaluate the effectiveness of sikthakadi taila in patients with Eczema (vicharchika) |
|
Scientific Title of Study
|
A randomized controlled clinical trial on the efficacy of sikthakadi taila 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 |
Komal Dnyaneshwar Pawar |
| Designation |
PG Scholar MD Agadatantra |
| Affiliation |
LRP Ayurvedic Medical College hospital PG institute and research centre urun islampur |
| Address |
Department of Agadatantra LRP Ayurvedic Medical College hospital
PG institute and research centre urun islampur
Address
Sangli
|MAHARASHTRA
415409
|India
Department of Agadatantra LRP Ayurvedic Medical College hospital PG institute and research centre urun islampur
Sangli
MAHARASHTRA
415409
India
Sangli
MAHARASHTRA
415409
India |
| Phone |
9834395566 |
| Fax |
|
| Email |
komaldpawar183@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwini Abhinandan Patil |
| Designation |
Professor of Agadatantra |
| Affiliation |
LRP Ayurvedic Medical College hospital PG Institute and research centre urun islampur |
| Address |
Department of Agadatantra LRP Ayurvedic Medical College hospital PG institute and research centre urun islampur
MAHARASHTRA
415409
India
Department of Agadatantra LRP Ayurvedic Medical College hospital PG institute and research centre urun islampur
MAHARASHTRA
415409
Sangli
MAHARASHTRA
415409
India |
| Phone |
9822735373 |
| Fax |
|
| Email |
drashwiniapatil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini Abhinandan Patil |
| Designation |
Professor of Agadatantra |
| Affiliation |
LRP Ayurvedic Medical College hospital PG Institute and research centre urun islampur |
| Address |
Department of Agadatantra LRP Ayurvedic Medical College hospital PG institute and research centre urun islampur
MAHARASHTRA
415409
India
Department of Agadatantra LRP Ayurvedic Medical College hospital PG institute and research centre urun islampur
MAHARASHTRA
415409
Sangli
MAHARASHTRA
415409
India |
| Phone |
9822735373 |
| Fax |
|
| Email |
drashwiniapatil@gmail.com |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic medical College hospital pg institute and research centre urun islampur Tal walwa Dist Sangli Maharashtra 415409 |
|
|
Primary Sponsor
|
| Name |
LRP Ayurvedic Hospital and Research centre |
| Address |
LRP Ayurvedic medical college hospital pg institute and research
centre urun islampur |
| 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 Komal Dnyaneshwar Pawar |
LRP Ayurvedic Medical College and Hospital PG Institute Reasearch Centre |
Department of Agad Tantra LRP Ayurvedic Medical College and Hospital PG Institute Reasearch Centre Islampur tal Walwa 415409 Sangli
Sangli
MAHARASHTRA |
9834395566
komaldpawar183@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Committe Of Loknete Rajarambapu Patil Ayurvedic Medical College and Hospital, Post Graduate Institute and Research Centre Urun Islampur Tal.Walwa Dist. Sangli Maharashtra 415409 |
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: Sikthakadi taila, Reference: Rastarangini, Route: Topical, Dosage Form: Taila, Dose: 1(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: application in gental way | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Arkadi taila, Reference: Sharangdhar Samhita, Route: Topical, Dosage Form: Taila, Dose: 1(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: gental application over site |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. The Patient having clinical signs and symptoms of vicharchika which are
mentioned in classical text will be selected for the study.
2. Patient of age group between 18 years to 60 years according to will be
selected for the study.
3. Despite of any gender and socioeconomic status patient will be selected
for the study.
4. The patient willing for trial |
|
| ExclusionCriteria |
| Details |
1. Patient of age group below 18 years and above 60 years will be excluded.
2. Patient on long term steroids and cytotoxic treatment.
3. Patient suffering from any systemic illness like Hypertension, Diabetes
mellitus, Human Immunodeficiency Virus, Tuberculosis, CANCER ect.
4. Pregnant and lactating women.
5. Patient having skin disease other than vicharchika. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the clinical efficacy of Sikthkadi taila in the management of vicharchika
Eczema. |
30 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study the literature on vicharchika.
2. To study the literature on Sikthakadi taila and Arka taila.
3. To prepare the sikthakadi tila as mentioned in the Sanhita.
4. To do physicochemical analysis of Sikthakadi tail.
5. To study the efficacy of Sikthakadi taila in the management of vicharchika.
6. To compare the efficacy of trial group and control group. |
30 Days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
27/04/2026 |
| 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
|
Randomised clinical control trial efficacy of sikthkadi taila in vicharchika with special referance to eczema, trial carried on total 60 patients with 30 trial group and 30 control group. Trial duration is 18 months. Observation and Result will be described as per the clinical study. After analysing data based on the following study discussion will be done. Conclusion will be drawn based on the data obtained, observations and result during the study. Data will be summarized based on observations and result. |