| CTRI Number |
CTRI/2025/07/090273 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Study to evaluate use of triphaladi churna orally and vidangadi churna massage in skin diseases. |
|
Scientific Title of Study
|
Three Arm Comparative Clinical Study To Evaluate The Efficacy of
Triphaladi Churna Orally, Vidangadi Udvartana Topically
and Both combined together in Vicharchika with special reference 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 Shreya Subhash Gunjal |
| Designation |
PG Scholar |
| Affiliation |
Arogyashala Rugnalaya Panchavati Nashik |
| Address |
OPD NO 13 Arogyashala Rugnalaya Panchavati Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
8369215082 |
| Fax |
|
| Email |
shreyagunjal53@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjivani Rathod |
| Designation |
HOD and PG Guide |
| Affiliation |
Arogyashala Rugnalaya Panchavati Nashik |
| Address |
Arogyashala Rugnalaya Panchavati Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
8007229141 |
| Fax |
|
| Email |
sanjivanirathod431@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shreya Subhash Gunjal |
| Designation |
PG Scholar |
| Affiliation |
OPD no 13 Arogyashala Rugnalaya Panchavati Nashik |
| Address |
OPD no 13 Arogyashala Rugnalaya Panchavati Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
8369215082 |
| Fax |
|
| Email |
shreyagunjal53@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Shreya Subhash Gunjal |
| Address |
OPD no 13 Arogyashala Rugnalaya Panchavati Nashik-422003, Maharashtra,India |
| Type of Sponsor |
Other [Govt aided ayurvedic 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 Shreya Gunjal |
Arogyashala Rugnalaya |
OPD no 13 Arogyashala Rugnalaya Panchavati Nashik
Nashik
MAHARASHTRA |
8369215082
shreyagunjal53@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: TVAGGATAKUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Triphaladi Churna, Reference: Yogratnakar, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vidangadi udvartana, Reference: Yogratnakar, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Takra), Additional Information: Along with triphaladi churna,ref- yogratnakar, route-oral,doses form-churna/powder,dose-5gm,frequency-bd,bhaishajya kaal-abhakta,duration-3 months,anupana-madhu | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vidangadi Udvartan, Reference: Yogratnakar, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Takra), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group: - 18 to 60 years.
2.Patients with clinical features of Vicharchika having signs and symptoms namely
Kandu(itching),Pidaka(Eruption),Vaivarnya(Depigmentation) and Srava (Discharge).
3. Patients of both Gender.
4. Understanding and being willing to sign the informed consent form. |
|
| ExclusionCriteria |
| Details |
1. Patient having severe systemic diseases or condition along with Vicharchika.
2. Pregnant & Lactating women.
3. Known case of Diabetes Mellitus.
4. Any other infective skin disorder |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To study the efficacy of Vidangadi Udvartana topically using EASI score.
2. To study the efficacy of Triphaladi Churna orally using EASI score.
3. To study the combined efficacy of Triphaladi Churna (orally) and Vidangadi Udvartana
(topically) in using EASI score.
|
12 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the effect of Triphaladi Churna (orally) with Vidangadi Udvartana (topically) in signs
and symptoms of Vicharchika .
|
12 Weeks |
|
|
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 |
|
Date of First Enrollment (India)
|
20/07/2025 |
| 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="0"
Months="3"
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
|
Mahakushta and Kshudrakushta are the two categories into which kushta roga is divided. Kshudrakushta has a description of Vicharchika. Ayurvedic dermatologist frequently face the kind of Kshudrakushta known as Vicharchika. Clinically eczema and vicharchika have frequently been linked. Modern medicine has therefore made significant advancements, notably in the field of dermatology, but when some medications like steroids are overused or abused, they have catastrophic adverse effects like nephrotoxicity, osteoporosis, skin cancer etc while Ayurveda heals many cases of eczema without any negative side effects , by balancing the Dosha and Dhatus. According to Ayurveda, Vicharchika is Rakta Pradoshaja Vikara with 3 dosha involvement and a dominant Kapha Dosha. I have choose Triphaladi Churna and Triphala- Vidang Churna 17. because of properties of these drugs. Triphala acts as a Rasayana, Kledagna, Tridoshaghna ( specially kaphaghna ) . Vidang is mentioned in Charak as Krumighna and Kushtagna. Pimpali acts as Rasayana , Pachana dravya and Vaat-Kaphaghna dravya. These all properties helps in reducing symptoms namely kandu(Itching), Srava(discharge), aaraktata(Redness) , daha(Burning), Vaivarnya (discolouration) in vicharchika according to Yoga Ratnakar. |