CTRI Number |
CTRI/2025/06/089193 [Registered on: 20/06/2025] Trial Registered Prospectively |
Last Modified On: |
11/06/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda Other (Specify) |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Efficacy of therapeutic emesis with Ikshvaku drug in Psoriasis |
Scientific Title of Study
|
A clinical study to evaluate the effectiveness of Vamana Karma with Ikshvaku in Eka-Kushtha |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Rajni Sharma |
Designation |
Ph.D Scholar |
Affiliation |
SGT University |
Address |
SGT University, D-Block, Room No.404, 4th floor, Gurugram, Harayana.
Gurgaon HARYANA 122505 India |
Phone |
7507373663 |
Fax |
|
Email |
rajnisharma.oct@gmail.com |
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Details of Contact Person Scientific Query
|
Name |
Rajni Sharma |
Designation |
Ph.D Scholar |
Affiliation |
SGT University |
Address |
SGT University, D-Block, Room No.404, 4th floor, Gurugram, Harayana.
Gurgaon HARYANA 122505 India |
Phone |
7507373663 |
Fax |
|
Email |
rekha.ayurveda@sgtuniversity.org |
|
Details of Contact Person Public Query
|
Name |
Dr Rekha Phull |
Designation |
Professor and HOD |
Affiliation |
SGT University |
Address |
SGT University, D-Block, Room No.404, 4th floor, Gurugram, Harayana.
Gurgaon HARYANA 122505 India |
Phone |
7507373663 |
Fax |
|
Email |
rekha.ayurveda@sgtuniversity.org |
|
Source of Monetary or Material Support
|
SGT Ayurveda Hospital, Kaliawas, Gurugram, Haryana. |
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Primary Sponsor
|
Name |
SGT University |
Address |
SGT University, Chandu, Budhera, Gurugram, Haryana, 122505 |
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 Rajni Sharma |
SGT Ayurveda Hospital |
SGT University, D-Block, Room No.404, 4th floor, Gurugram, Harayana. Gurgaon HARYANA |
7507373663
rajnisharma.oct@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
institutional ethical commiittee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:L500||Allergic urticaria. Ayurveda Condition: EKAKUSHTHAH, (2) ICD-10 Condition:L503||Dermatographic urticaria. Ayurveda Condition: EKAKUSHTHAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Procedure | - | dIpana , दीपन pachana, ghritapana, vamana | (Procedure Reference: charak samhita kalpa sthana chapter 1, Procedure details: deepana pachana followed by ghitapana & vamana) (1) Medicine Name: Ikshvaku, Reference: kalpasthana , Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 3(NA), Frequency: od, Duration: 1 Days |
|
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Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1 Patients who have scored more than 0 for Asvedanam, Mahavastu & Matsyashakalata lakshana in assessment criteria.
2 Patients having signs and symptoms of Eka-kushtha according to Charaka Samhita.
3 Age group from 20 to 60 yrs.
4 Patient of either sex.
5 Vamanarha patients.
|
|
ExclusionCriteria |
Details |
• Patients with complications like Cardiac problems, emphysema, carcinoma, etc. will be excluded.
• Pregnant woman and lactating mothers will be excluded.
• The patients above 60yrs and below 18yrs will be excluded.
|
|
Method of Generating Random Sequence
|
Random Number Table |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Relief in the signs and symptoms of Eka Kushtha like matsyasakalta, aswednam etc. |
4 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
NIL |
NIL |
|
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
|
N/A |
Date of First Enrollment (India)
|
30/06/2025 |
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="1" 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
|
In Ayurveda, skin diseases are included under the heading of Kushtha or Kshudra Rogas. Out of them Kshudra Kushtha is the Eka-kushtha which can be correlated up to certain extent with Psoriasis. It is chronic, non-infectious & common skin disease of today’s time. It is a very attention seeking problem approximately 2-3 % (125 million) population of the world suffering from the disease Eka-kushtha may be characterized as follows 1. Absence of perspiration (Asvedanam) 2. Extensive localization (Mahavastu) 3. It resembles the scales of fish (Matsyashakalata). Eka-kushtha is curable disease but its relapsing nature causes more harassment for the patient. It is correlated to certain extent with Psoriasis. NEED AND SIGNIFICANCE: There are many studies carried out on Vamana Karma by Madanphala and Jeemutaka but there are no studies reported on the use of Ikshvaku as a Vamaka dravya. So unexplored Vamaka dravya should be addressesd. The present study will evaluate the efficacy of Ikshvaku as a Vamaka dravya in Eka-kushtha. HYPOTHESIS: Proper Vamana karma with Ikshvaku will remove Eka-kushtha. H0= Ikshvaku don’t have any effect in Eka- Kushtha H1= Ikshvaku has significant effect in Eka-Kushtha. AIM To study the efficacy of Vamana karma using Ikshvaku in the patients of Eka-Kushtha. OBJECTIVES · To study the effects of Ikhvaku as Vamakadravya in Eka-kushtha. · To study the reduction in the symptoms of Eka-kushtha. MATERIALS & METHODS · Ikshvaku seeds -whole fruit decoction with seed powder decoction(13gm seed powder) · Yashtimadhu Kashayam- 3 to 5 litre · Madhu- 40-60 gm · Saindhav- 10 gm · Cows milk- 1.5 lit- 2 lit · All these drugs and its raw materials will be purchased from Khari Baoli of Delhi market and the authentication and standardization will be done. · Fresh Vamaka Kalpa will be prepared at the time of clinical trial as the Standard Operative Procedure given in Charaka Samhita and under the guidance of guide.
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