| CTRI Number |
CTRI/2025/01/079424 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
20/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Eka kustha(Psoriasis) management through ayurveda |
|
Scientific Title of Study
|
A Study to Evaluate the Efficacy of Rajavrikshadi Kwath Ghanvati
and Kushthadi Lepa in the Management of Eka Kustha (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 Shrikant Lodhi |
| Designation |
MD Scholar |
| Affiliation |
Pt Khushilal Sharma Govt Ayurveda College and Institute Bhopal MP |
| Address |
PG Department of Kayachikitsa Pt Khushilal Sharma Govt Ayurveda College and Institute Bhopal Madhya Pradesh 462003 (India)
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
7354160830 |
| Fax |
|
| Email |
shrikantpatel222@gmail.comM |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivek Sharma |
| Designation |
Lecturer |
| Affiliation |
Pt Khushilal Sharma Govt Ayurveda College and Institute Bhopal Madhya Pradesh |
| Address |
PG Department of Kayachikitsa Pt Khushilal Sharma Govt Ayurveda College and Institute Bhopal Madhya pradesh 462003 (India)
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9827937247 |
| Fax |
|
| Email |
drvivek.sharma13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vivek Sharma |
| Designation |
Lecturer |
| Affiliation |
Pt Khushilal Sharma Govt Ayurveda College and Institute Bhopal Madhya Pradesh |
| Address |
PG Department of Kayachikitsa Pt Khushilal Sharma Govt Ayurveda College and Institute Bhopal Madhya pradesh 462003 (India)
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9827937247 |
| Fax |
|
| Email |
drvivek.sharma13@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kaya Chikitsa Pt Kls Govt Autonomous Ayurveda College and Institute Bhopal Madhya pradesh 462003 |
|
|
Primary Sponsor
|
| Name |
Pt Khushilal Sharma Govt Autonomous Ayurveda College and Institute Bhopal Madhya pradesh |
| Address |
PG Department of Kayachikitsa Department of Kaya Chikitsa Pt Khushilal Sharma Govt Ayurveda College and Institute Bhopal Madhya pradesh 462003 |
| Type of Sponsor |
Government funding agency |
|
|
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 Shrikant Lodhi |
Pt Khushilal Sharma Govt Ayurveda College and Institute Bhopal Madhya pradesh |
Room No.221 PG Department of Kayachikitsa Pt Khushilal Sharma Govt Ayurveda College and Institute Bhopal Madhya pradesh
Bhopal
MADHYA PRADESH |
7354160830
shrikantpatel222@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Pt Khushilal Sharma Govt Ayurveda College and Institute Bhopal Madhya Pradesh |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rajvrikshadi Kwath ghanavati , Reference: Raj nighantu, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Kushthadi lepa, Reference: Charaka chikitsa , Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Placebo | 2 capsule bd 45days |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having the clinical feature of Eka kustha.
2.Patients who have given written consent to participate in the study.
3Patients between the age group of 21-60 years of either sex. |
|
| ExclusionCriteria |
| Details |
1.Age: - less than 21year and more than 60 years.
2. Patient suffering from diabetes mellitus, cancer, cardiac problems, uncontrolled
hypertension, acquired immunodeficiency syndrome (AIDS), tuberculosis (TB), renal
disorder.
3. Other co-skin disease and psoriatic arthropathy.
4. Pregnant women and lactating mother. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
In Ayurveda kustha has been included in asth mahagada , Although kustha is said to be of
innumerous types a total of 18 types are widely accepted. Eka kushtha is one of the 11 types of kshudra kustha with predominant involvement of vata & kapha dosha,although all types of kushtha are three types in nature. A similar clinical entity Psoriasis has been described in contemporary modern medical science
which closely resembles Eka kustha in its sign and symptomatology. After the completion of clinical trial it is expected that the efficacy of Rajavrikshadi
Kwath Ghanavati along with Kusthadi Lepa in the Management of Eka Kushtha”
(Psoriasis) for the explain in the management of psoriasis. |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
After the completion of clinical trial it is expected that the efficacy of Rajavrikshadi
Kwath Ghanavati along with Kusthadi Lepa in the Management of Eka Kushtha”
(Psoriasis) for the explain in the management of psoriasis. |
12 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
10/02/2025 |
| 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="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
|
After the completion of clinical trial it is expected that the efficacy of Rajavrikshadi Kwath Ghanavati along with Kusthadi Lepa in the Management of Eka Kushtha” (Psoriasis) for the explain in the management of psoriasis. |