| CTRI Number |
CTRI/2025/07/090053 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
27/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
CLINICAL STUDY OF VAJRAKA TAILA IN VICHARCHIKA ( ECZEMA) |
|
Scientific Title of Study
|
A RANDOMIZED CLINICAL STUDY ON THE ROLE OF VAJRAKA TAILA IN THE MANAGEMENT OF 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 |
DR RITU SINGH |
| Designation |
PHD SCHOLAR |
| Affiliation |
DESH BHAGAT UNIVERSITY, MANDI GOBINDGARH |
| Address |
DEPARTMENT OF AGADA TANTRA
NH-44, Amloh Road, Mandi Gobindgarh District Fatehgarh Sahib, Punjab- 14, Mandi Gobindgarh, Punjab 147301
DEPARTMENT OF AGADA TANTRA
Off to NH-44, Amloh Road, Mandi Gobindgarh District Fatehgarh Sahib, Punjab- 14, Mandi Gobindgarh, Punjab 147301
Meerut
UTTAR PRADESH
250001
India |
| Phone |
8791600581 |
| Fax |
|
| Email |
RITUDR100207@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RAKESH PAWAR |
| Designation |
PROFESSOR, DEPARTMEN OF KAYA CHIKTSA |
| Affiliation |
DESH BHAGAT UNIVERSITY, MANDI GOBINDGARH |
| Address |
DEPARTMENT OF KAYA CHIKITSA
NH-44, Amloh Road, Mandi Gobindgarh District Fatehgarh Sahib, Punjab- 14, Mandi Gobindgarh, Punjab 147301
DEPARTMENT OF KAYA CHIKITSA
NH-44, Amloh Road, Mandi Gobindgarh District Fatehgarh Sahib, Punjab- 14, Mandi Gobindgarh, Punjab 147301
Meerut
UTTAR PRADESH
250001
India |
| Phone |
7505039976 |
| Fax |
|
| Email |
drpawar3757@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RITU SINGH |
| Designation |
PHD SCHOLAR |
| Affiliation |
DESH BHAGAT UNIVERSITY, MANDI GOBINDGARH |
| Address |
DEPARTMENT OF AGADA TANTRA
NH-44, Amloh Road, Mandi Gobindgarh District Fatehgarh Sahib, Punjab- 14, Mandi Gobindgarh, Punjab 147301
DEPARTMENT OF AGADA TANTRA
NH-44, Amloh Road, Mandi Gobindgarh District Fatehgarh Sahib, Punjab- 14, Mandi Gobindgarh, Punjab 147301
Meerut
UTTAR PRADESH
250001
India |
| Phone |
8791600581 |
| Fax |
|
| Email |
RITUDR100207@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DESH BHAGAT UNIVERSITY |
| Address |
NH-44, Amloh Road, Mandi Gobindgarh District Fatehgarh Sahib, Punjab- 14, Mandi Gobindgarh, Punjab 147301 |
| 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 RITU SINGH |
DESH BHAGAT AYURVEDIC COLLEGE AND HOSPITAL |
DEPARTMENT OF KAYA CHIKITSA OPD AND IPD
NH-44, Amloh Road, Mandi Gobindgarh District Fatehgarh Sahib, Punjab- 14, Mandi Gobindgarh, Punjab 147301
Fatehgarh Sahib
PUNJAB |
8791600581
RITUDR100207@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| UNIVERSITY ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L239||Allergic contact dermatitis, unspecified cause. Ayurveda Condition: VICARCIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | aBya~ggaH, अभ्यंग | (Procedure Reference: Charak Samhita, Procedure details: local application of Vajraka Taila on the site of lesion)
(1) Medicine Name: Vajraka Taila, Reference: Sharangdhara Samhita Madhyama Khanda 9/198, Route: Topical, Dosage Form: Taila, Dose: 2(ml), Frequency: bd, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex with the age group between 18 - 60 years.
Patients of both sexes.
Patient presenting with the symptoms of Vicharchika.
|
|
| ExclusionCriteria |
| Details |
Patient suffering from chronic skin disease.
Patients on oral Corticosteroid treatment.
Lesions with secondary infections.
Patients suffering from systemic disorders under other medications. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Kandu (Itching)
Daha (Burning sensation).
Ruja (pain) |
0th,30th |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pidaka (Eruptions)
Shyavata (Erythema)
Hyper pigmentation).
Srava (Oozing Lesions, Crusted lesion)
Rukshata (Dry and scaly skin/Cracking and Fissures/Thickened crusty skin)
|
0th, 30th |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
21/07/2025 |
| 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 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 - YES
- What data in particular will be shared?
Response (Others) - NIL
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response (Others) - NIL
- Who will be able to view these files?
Response (Others) - NIL
- For what types of analyses will this data be available?
Response (Others) - NIL
- By what mechanism will data be made available?
Response (Others) - NIL
- For how long will this data be available start date provided 01-07-2025 and end date provided 31-12-2025?
Response (Others) - NIL
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Vicharchika is a type of Kshudra kushtha often encountered by Ayurvedic Dermatologists characterized with symptoms namely Kandu, Srava, Pidika and shyava varna. Vicharchika is often correlated to eczema based on the clinical presentations. No satisfactory treatment is available in contemporary medical practise. Main line of treatment for Vicharchika is Ayurveda is Shodhan & Shaman. In the Ayurvedic text all skin diseases were included under the Kushta roga. Which is classified in two divisions i.e. Maha Kushta and Kshudrakushta. Vicharchika is described under Kshudrakushta. The clinical presentation of Vicharchika similar to Eczema in modern dermatology.
Vicharchika is Tridoshaja Kapha Pradhana vyadhi so humid cold, watery contact may increase symptoms of Vicharchika. Excessive intake of Lavana, Katu and Madhura rasa are most common causative factor for disease like Vicharchika. Viharaja nidana like Diwaswapna, Industrial pollution is also considering as main causative factors for Vicharchika. It might be categorized as eczema in today’s Vicharchika’ s perspective. Such therapies need long-term inhibitory and symptoms (topical and systemic) maintenance. Ayurvedic ideas Kustha and Kshudra Kustha seem to be broad themes featuring effective managerial guidelines. At present era there are many cases related to Vicharchika therefore the topic was cs. The entitled “A Randomized Clinical Study on The Role of Vajraka Taila in The Management of Vicharchika W.S.R. Eczema” |