| CTRI Number |
CTRI/2025/08/093186 [Registered on: 18/08/2025] Trial Registered Prospectively |
| Last Modified On: |
15/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing effect of Haritkyadi Ointment and orally Guduchi ghan vati with White Paraffin and orally Tab Methotrexate n the management of Ekakustha. |
|
Scientific Title of Study
|
Evaluation of Comparative Efficacy of Haritkyadi Ointment with Guduchi Ghan Vati Versus White paraffin with Tablet Methotrexate in the Management of Ekakustha-A Randomized Controlled Trial |
| 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 Nidhi Shetiya |
| Designation |
PG Scholar |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Wardha Maharashtra |
| Address |
Department of Kayachikitsa Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Wardha Maharashtra
Department of Kayachikitsa Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Wardha Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
8668875408 |
| Fax |
|
| Email |
nidhishetiya6238@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sourabh Deshmukh |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Wardha Maharashtra |
| Address |
Department of Kayachikitsa Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Wardha Maharashtra
Department of Kayachikitsa Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Wardha Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
9404337799 |
| Fax |
|
| Email |
ayurrulz@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sourabh Deshmukh |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Wardha Maharashtra |
| Address |
Department of Kayachikitsa Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Wardha Maharashtra
Department of Kayachikitsa Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Wardha Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
9404337799 |
| Fax |
|
| Email |
ayurrulz@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Wardha Maharashtra |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Wardha Maharashtra |
| Address |
Department of Kayachikitsa Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Wardha Maharashtra |
| 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 Nidhi Shetiya |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Wardha Maharashtra |
Department of Kayachikitsa Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Wardha Maharashtra
Department of Kayachikitsa Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Wardha Maharashtra
Wardha
MAHARASHTRA |
08668875408
nidhishetiya6238@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Wardha Maharashtra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L409||Psoriasis, unspecified. Ayurveda Condition: EKAKUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | White paraffin and Tab Methotrexate | Medicine Name: White paraffin , Route: Topical, Dosage Form:1 Frequency:bd ,Bhaishajya Kal : Antarabhakta,Duration : 60 days Additional Information : White Paraffin and orally tab Methotrexate (7.5 mg weekly) | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Haritkyadi ointment, Reference: Gadanigrah, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(NA), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: Haritkyadi Ointment and orally Guduchi ghan Vati |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient willing to participate with written informed consent
Patient between the age group of 18 to 60 years of either Sex
With moderate to severe Psoriasis with PASI score greater than 10 and willing to participate in
the study.
Patient having clinical feature of Ekakushtha i.e. of Aswedana, which means dry and
rough lesions, Mahavastu, which covers the entire body, Matsyashakalawat is well
demarked raised patches with large silvery loose scaling (skin resembles scales of
fish), and Krishna-Aruna Varnata (blackish in color). |
|
| ExclusionCriteria |
| Details |
Chronic cases of Psoriasis more than 5 years.
Known case of Diabetes, Cancer, AIDS, Tuberculosis And Nervous System,
Renal, Hepatic, Endocrine, Gastrointestinal, or Pulmonary Disease
Pregnant or Lactating Women.
Subjects with other dermatological infectious conditions.
Major surgical procedure within 28 days prior to randomization.
Any condition that in opinion of the investigator, does not justify the patient
participation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Haritkyadi Ointment and Guduchi Ghan Vati will reduce subjective assessment criteria like Aswedanam,Mahavastum,Matsyashakalopamam , Krishhna Arun Varnata in 8 weeks. |
Haritkyadi Ointment and Guduchi Ghan Vati will reduce subjective assessment criteria like Aswedanam,Mahavastum,Matsyashakalopamam , Krishhna Arun Varnata in 8 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Immunity Boosting |
60 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/01/2026 |
| 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="2"
Months="0"
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
|
The Volunteers will be informed about the study protocol. Willing participants will be randomly selected as per computerized generated table . Clinical research format will be prepared and validated .Prior to study approval will be taken from IEC ,MGACHRC,Salod (H) Wardha and CTRI registeration will be done .After selection each participants will be tested individually and selected according to Inclusion criteria .They are divided into two groups .The trial is Randomized Open Labelled Controlled Trial . it will include a 60 days treatment period and follow up on 15th ,30th ,45th ,60th day |