| CTRI Number |
CTRI/2024/11/076740 [Registered on: 13/11/2024] Trial Registered Prospectively |
| Last Modified On: |
25/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect Of Abhaya Arishtadi Ghana Vati in Psoriasis. |
|
Scientific Title of Study
|
Randomized Clinical Trial On Effect Of Abhaya Arishtadi Ghana Vati In The Management Of Psoriasis. |
| 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 Dhara Deliwala |
| Designation |
PhD Scholar |
| Affiliation |
G J Patel Institute of Ayurveda Studies and Research Center |
| Address |
Department of Kayachikitsa, G J Patel Institute of Ayurveda Studies and Research Center, New Vallabh Vidyanagar, Anand
Anand GUJARAT 388121 India |
| Phone |
9426712776 |
| Fax |
|
| Email |
drdhara.deliwala@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Yogesh Deole |
| Designation |
Professor |
| Affiliation |
G J Patel Institute of Ayurveda Studies and Research Center |
| Address |
Department of Kayachikitsa, G J Patel Institute of Ayurveda Studies and Research Center, New Vallabh Vidyanagar, Anand
Anand GUJARAT 388121 India |
| Phone |
9974999309 |
| Fax |
|
| Email |
yogesh.deole@cvmu.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Dhara Deliwala |
| Designation |
PhD Scholar |
| Affiliation |
G J Patel Institute of Ayurveda Studies and Research Center |
| Address |
Department of Kayachikitsa, G J Patel Institute of Ayurveda Studies and Research Center, New Vallabh Vidyanagar, Anand
Anand GUJARAT 388121 India |
| Phone |
9426712776 |
| Fax |
|
| Email |
drdhara.deliwala@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
G J Patel Institute of Ayurveda Studies and Research Center |
| Address |
G J Patel Institute of Ayurveda Studies and Research Center, New Vallabh Vidyanagar, Anand, Gujarat- 388121 |
| 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 Dhara Deliwala |
Shri V M Mehta Institute of Ayurveda |
Department of Kayachikitsa, Shri V M Mehta Institute of Ayurveda, Rajkot- Kalawad Highway, Village: Anandpar Rajkot - 361162 Rajkot GUJARAT |
9426712776
drdhara.deliwala@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
| INSTITUTIONAL HUMAN ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L400||Psoriasis vulgaris. Ayurveda Condition: EKAKUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Abhaya Arishtadi Ghana Vati , Reference: Chakradatta Kushtha Chikitsa/64, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: Normal water), Additional Information: for local application Bruhath Danthapala tail will be given | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kaishore Guggulu , Reference: Sharangadhara Samhita, Madhyama khanda, chapter no. 7- verse 70-81, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: Manjishthadi kwatha), Additional Information: Kaishore Guggulu will be given with 40ml Manjishthadi Kwatha both the time
- for local application like interventional group the local application of Bruhath Danthapala Taila will be given |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient who fulfills the diagnostic criteria of psoriasis.
2. Patient who has chronicity of less than 5 years will be taken.
3. PASI score – 0-10 will be taken. |
|
| ExclusionCriteria |
| Details |
1. Pregnant and lactating women.
2. Patients with any other skin diseases.
3. Patients with associated diseases like cardiovascular disorders, hyperthyroidism or
hypothyroidism, cancer, tuberculosis, heart diseases, psoriatic arthritis, and kidney and
liver disorders.
4. Patients who have taken medication of corticosteroids or drugs within the last 3 months |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in the subjective and objective criteria of psoriasis with intervention of Abhaya Arishtadi Ghana Vati.
|
7th,14th,21st,30th days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To explore the etio-pathological role of dietary factor in psoriasis.
|
1month |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
01/01/2025 |
| 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 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
|
Psoriasis, often equated with Ekakushtha in Ayurveda, is a chronic, immune-mediated skin disorder that significantly impacts the quality of life of affected individuals. Despite advancements in modern dermatology, the management of psoriasis remains challenging due to its recurrent nature, potential side effects of long-term allopathic treatments, and the lack of a definitive cure. This has led to an increasing interest in exploring alternative and complementary therapies, particularly those rooted in traditional systems of medicine like Ayurveda. In recent years, there has been a growing recognition of the potential benefits of Ayurvedic treatments in managing chronic conditions like psoriasis. Formulations such as Abhaya Arishtadi Ghana Vati have been traditionally used in Ayurveda to treat kushtha due to their properties in balancing doshas, enhancing digestion, and detoxifying the body. However, there is a paucity of rigorous clinical research validating these formulations’ efficacy in managing psoriasis, particularly in the context of randomized clinical trials. The study will utilize randomization to allocate patients into two groups: an interventional group and a comparator group. In the interventional group, patients will receive Abhaya Arishtadi Ghana Vati at a dose of 3 tablets twice daily, combined with the topical application of Bruhath Danthapala Taila. In the comparator group, patients will be administered Kaishore Guggulu (3 tablets twice daily) alongside Manjishthadi Kwatha (40 ml twice daily) with the same topical application of Bruhath Danthapala Taila. Prior to treatment in both groups, Koshthashuddhi (bowel cleansing) will be performed using Triphala Kwatha and Eranda Taila. Patients will also be advised to follow a specific pathya ahara (wholesome diet) throughout the one-month treatment period.
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