| CTRI Number |
CTRI/2024/12/078563 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
22/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of ayurveda in the Management of Vicharchika (Eczema) |
|
Scientific Title of Study
|
Efficacy of Ekvimshati Guggulu and Khadirashthak Kwatha in combination with Durvadya Taila in the management of Vicharchika w.s.r. Eczema: an open-label randomised comparative study |
| 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 Rubi Vishwakarma |
| Designation |
PG SCHOLAR |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Ayurvedic and Unani Tibbia College and Hospital, PG Dept of Kayachikitsa, Karol Bagh, New Delhi
Ayurvedic and Unani Tibbia College and Hospital, PG Dept of Kayachikitsa, Karol Bagh, New Delhi
Central
DELHI
110005
India |
| Phone |
7350860241 |
| Fax |
|
| Email |
rubiv1104@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujata Yadav |
| Designation |
Associate Professor and Head of Department |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Ayurvedic and Unani Tibbia College and Hospital, PG Dept of Kayachikitsa, Karol Bagh, New Delhi
Ayurvedic and Unani Tibbia College and Hospital, PG Dept of Kayachikitsa, Karol Bagh, New Delhi
Central
DELHI
110005
India |
| Phone |
9810571653 |
| Fax |
|
| Email |
sujatakcdelhi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujata Yadav |
| Designation |
Associate Professor and Head of Department |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Ayurvedic and Unani Tibbia College and Hospital, PG Dept of Kayachikitsa, Karol Bagh, New Delhi
Ayurvedic and Unani Tibbia College and Hospital, PG Dept of Kayachikitsa, Karol Bagh, New Delhi
Central
DELHI
110005
India |
| Phone |
9810571653 |
| Fax |
|
| Email |
sujatakcdelhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurvedic and Unani Tibbia College and Hospital, Karol Bagh, New Delhi-110005 |
|
|
Primary Sponsor
|
| Name |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Ayurvedic and Unani Tibbia College and Hospital,Karol Bagh, New
Delhi-110005 |
| Type of Sponsor |
Government 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 Sujata Yadav |
Ayurvedic and Unani Tibbia College and Hospital |
Seminar Room,PG Department of Kayachikitsa, Ayurvedic and Unani Tibbia College and Hospital,Karol Bagh, New
Delhi-110005
Central
DELHI |
9810571653
sujatakcdelhi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Ayurvedic and Unani Tibbia college and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L20-L30||Dermatitis and eczema. Ayurveda Condition: VICARCIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Khadirashthaka Kwatha, Reference: Yogratnakaar - Kushtha chikitsa prakaranam shlok no 63, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Water), Additional Information: -Local Application Of Durvadya Taila (BID) | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ekvimshati Guggulu, Reference: Yogratnakaar - Kushtha chikitsa prakaranam shlok no 88-92, Bhavprakash Kushtharogadhikar 54/68-72, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Lukewarm Water), Additional Information: -Local Application of Durvadya Taila (BID) |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Individuals with Eczema confirmed according to symptoms of Vicharchika explained in the ayurvedic texts (Brihattrayi) as well as the American Academy of Dermatology Criteria. 2 Individuals of either gender aged 16 to 70 years40. 3 EASI score less than or equal to 50. |
|
| ExclusionCriteria |
| Details |
1. Populations with skin diseases other than eczema and Scabies, Seborrheic dermatitis, Contact dermatitis (irritant or allergic), Ichthyoses, Cutaneous T-cell lymphoma, Psoriasis, Photosensitivity dermatoses, Immune deficiency diseases, Erythroderma of other causes mentioned in exclusionary criteria of diagnostic criteria for Atopic Dermatitis in American Academy of Dermatology.
2. Cutaneous infection within 1 week before the screening visit or any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics, or antifungals within 1 week before the screening visit.
3. Patients with comorbid conditions such as known cases of Diabetes mellitus (Fasting blood sugar
more than 126mg/dl), Grade 2 hypertension (BP more than 160/100mmhg), Renal impairment (Sr. creatinine more than 1.2 mg/dl),
Hepatic impairment (SGOT and SGPT more than three times the upper limit).
4. Subjects with a history of any cardiovascular disease such as coronary artery disease, congestive heart failure, valvular heart disease, etc.
5. Subjects with comorbidities such as Tuberculosis, immunocompromised states such as HIV, history or active malignancy etc.
6. Pregnant women and lactating mothers.
7. Participants who had received topical corticosteroids, systemic steroids, immunosuppressants, and immunomodulators one month before screening.
8. Participants with a history of allergic reactions to ayurvedic drugs and those who exhibit sensitivity in the patch test to the topical medication.
9. Currently participating or participated in any other study of a drug, within the past 6 months before the screening visit. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of participants achieving more than or equal to 50% improvement in EASI (Eczema Area and Severity Index) OR more than or equal to 6.6 point reduction in EASI score |
Day 1, Day 91 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in severity of dermatitis symptoms measured by vIGA-AD11(Validated Investigator Global Assessment scale for Atopic Dermatitis) and Itch NRS.
2. Change in serum IgE levels and AEC as a marker of allergic inflammation.
3. Proportion of participants achieving more than or equal to 4 point reduction in DLQI (Dermatology Life Quality Index).
4. Digital Photo documentation of the affected skin areas will be taken at baseline and after the treatment to visually document changes in the condition. |
Day 1, Day 91 |
|
|
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)
|
01/02/2025 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 (eczema), a chronic inflammatory skin condition, is categorized under Kshudra Kushtha in Ayurveda. It is characterized by symptoms such as itching (Kandu), discharge (Srava), vesicles (Pidika), dryness (Rukshata), and discoloration (Shyava Vrana). This condition, while not life-threatening, significantly impacts the quality of life, causing both physical discomfort and emotional distress. The psychological toll is substantial, as individuals with eczema often experience sleep disturbances, social withdrawal, and restrictions in daily activities. The prevalence of eczema is notably high, affecting approximately 20% of children and 10% of adults worldwide. It ranks 15th among all non-fatal diseases in terms of disability-adjusted life years. Eczema is a highly prevalent, non-communicable chronic skin disorder with increasing incidence and recurrence rates. It is frequently associated with environmental, dietary, and psychological stressors, which contribute to its chronicity and progression. Modern dermatological treatments, such as antihistamines, corticosteroids, and immunosuppressive therapies, primarily focus on symptom management but come with significant side effects, including skin thinning, nephrotoxicity, and increased susceptibility to infections. Additionally, these treatments often fail to address the root cause, and relapses are common, leading to long-term dependency on medications. In contrast, Ayurveda offers a holistic approach to managing eczema by addressing the underlying imbalances in the Doshas (biological energies) and Dhatus (body tissues). Ayurvedic treatments aim to detoxify the body, restore balance, and promote natural healing. This study investigates the efficacy of Ekvimshati Guggulu, Khadirashthak Kwatha, and Durvadya Taila in the treatment of Vicharchika, focusing on their potential to provide long-term relief with minimal adverse effects. The study seeks to explore safer, more effective alternatives to conventional therapies and contribute to the growing body of evidence supporting Ayurvedic interventions for chronic skin conditions. |