| CTRI Number |
CTRI/2022/05/042491 [Registered on: 12/05/2022] Trial Registered Prospectively |
| Last Modified On: |
10/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of ‘Darvyadi Kwath’ and‘Triphla Kwath’ in
Ekakushtha(Plaque psoriasis) |
|
Scientific Title of Study
|
A comparative study to evaluate the effectiveness of ‘Darvyadi Kwath’ and ‘Triphla Kwath’ in management of
Ekakushtha(Plaque psoriasis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yogesh Kumar Pandey |
| Designation |
Associate Professor(Dept of Kayachikitsa) |
| Affiliation |
Ch Brahm Prakash Ayurved Charak Sansthan |
| Address |
Ch Brahm Prakash Ayurved Charak Sansthan
Khera Dabar
Najafgarh
South West Delhi
New Delhi 110073
India
South West
DELHI
110073
India |
| Phone |
9013858523 |
| Fax |
|
| Email |
dryogeshpandey@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka |
| Designation |
MD Scholar ( Kayachikitsa) |
| Affiliation |
Ch Brahm Prakash Ayurved Charak Sansthan |
| Address |
Ch Brahm Prakash Ayurved Charak Sansthan
Khera Dabar
Najafgarh
South West Delhi
New Delhi 110073
India
South West
DELHI
110073
India |
| Phone |
7000940468 |
| Fax |
|
| Email |
kasdepriyanka15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka |
| Designation |
MD Scholar ( Kayachikitsa) |
| Affiliation |
Ch Brahm Prakash Ayurved Charak Sansthan |
| Address |
Ch Brahm Prakash Ayurved Charak Sansthan
Khera Dabar
Najafgarh
South West Delhi
New Delhi 110073
India
South West
DELHI
110073
India |
| Phone |
7000940468 |
| Fax |
|
| Email |
kasdepriyanka15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Kayachikitsa
Ch Brahm Prakash Ayurved Charak Sansthan
Khera Dabar
Najafgarh
South West Delhi
New Delhi 110073
India
|
|
|
Primary Sponsor
|
| Name |
Ch Brahm Prakash Ayurved Charak Sansthan |
| Address |
Khera Dabar
Najafgarh
South West Delhi 110073
New Delhi 110073
India
|
| 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 Yogesh Kumar Pandey |
Ch Brahm Prakash Ayurved Charak Sansthan |
Department of kayachikitsa
Ch Brahm Prakash Ayurved Charak Sansthan
Khera Dabar
Najafgarh
South West Delhi
New Delhi 110073
India
South West
DELHI |
9013858523
dryogeshpandey@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC CBPACS |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Triphala Kwath, Reference: Charak Chikitsa seven, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: nil | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Darvyadi Kwath, Reference: Ashtang Hridya Chikitsa Sthan, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: nil |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a. Age: 20 year to 60years.
b. Sex: both sex(male and females).
c. Patient having the clinical feature of Ekakushtha(Plaque Psoriasis).
d. Patient having chronicity of psoriasis less than 5 year and more than 6 month.
e.Patient willing to give consent for trial with firm residential address and contact. |
|
| ExclusionCriteria |
| Details |
a. Age: - less than 20 year and more than 60 years.
b. Patient suffering from Diabetes Mellitus, Cancer, Cardiac Problems,
Uncontrolled Hypertension, Acquired Immunodeficiency Syndrome (AIDS),
Tuberculosis (TB), Renal
c. Disorder.
d. Other co-skin disease.
e. Pregnant women and lactating mother.
f. Drug or Alcohol Abuse: A Known or suspected history of chronic alcohol or drug abuse.
g. Hypersensitivity to any of the drugs to be used in study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Psoriasis Area And Severity Index(PASI) Score |
DAY 1
DAY 15
DAY 30
DAY 45 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in symptom severity of Ekkushtha(Plaque Psoriasis).
|
DAY 1
DAY 15
DAY 30
DAY 45 |
| Improvement in inflammatory markers (ESR, CRP). |
DAY 1
DAY 15
DAY 30
DAY 45 |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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 4 |
|
Date of First Enrollment (India)
|
17/05/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Ekakushtha is one of 18 types of kushtha described in Samhitas. Although Ekakushtha is said to be Vata- Kaphaja, there is involvement of all the three doshas in all types of kushtha.The clinical features of Ekakushtha as described in Ayurveda literature are Aswedanamm(~anhidrosis),Mahavastu(~extensively spreading dermoses) and Matsya-Shaklopam (~desquamation), Krushna – Aruna Varna (~erythmatous). Psoriasis is a chronic, disfiguring, inflammatory and proliferative condition of skin. It has several subtypes but plaque psoriasis is its most common variant. The most characteristic lesion consists of red, scaly, sharply demarcated, indurated papules and/or plaques, often present over the scalp and extensor surfaces of skin but can be seen anywhere on the body. This study is to compare the effectiveness of Darvyadi Kwath and Triphala Kwath in management of Ekakushta (Plaque Psoriasis).Total number of the patient is 56. 28 in each group.In group A Darvyathi kwath is given in dose of 40ml twice a day empty stomach.In group B Triphala Kwath is given in dose of 40ml twice a day empty stomach. Study design is single centered, open label, randomised , interventional type ,comparative study. |