| CTRI Number |
CTRI/2020/12/029548 [Registered on: 03/12/2020] Trial Registered Prospectively |
| Last Modified On: |
21/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic management of Psoriasis. |
|
Scientific Title of Study
|
A comparative study of Lelitaka-Makshika Yoga processed with Amalaki Svarasa and Lelitaka-Makshika Yoga processed with Jatipatra Svarasa in the management of 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 Palak S Singhal |
| Designation |
PG Scholar |
| Affiliation |
J S Ayurveda Mahavidyalaya |
| Address |
Department of Kayachikitsa,
J S Ayurveda Mahavidyalaya, College Road, Nadiad.
Department of Kayachikitsa,
J S Ayurveda Mahavidyalaya, College Road, Nadiad.
Kheda
GUJARAT
387001
India |
| Phone |
9727716549 |
| Fax |
|
| Email |
palaksinghal96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhaval Dholakiya |
| Designation |
Reader |
| Affiliation |
J S Ayurveda Mahavidyalaya |
| Address |
Department of Kayachikitsa,
J S Ayurveda Mahavidyalaya, College Road, Nadiad
Department of Kayachikitsa,
J S Ayurveda Mahavidyalaya, College Road, Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
7016786089 |
| Fax |
|
| Email |
vddhavaldholakiya1910@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhaval Dholakiya |
| Designation |
Reader |
| Affiliation |
J S Ayurveda Mahavidyalaya |
| Address |
Department of Kayachikitsa,
J S Ayurveda Mahavidyalaya, College Road, Nadiad.
Department of Kayachikitsa,
J S Ayurveda Mahavidyalaya, College Road, Nadiad.
Kheda
GUJARAT
387001
India |
| Phone |
7016786089 |
| Fax |
|
| Email |
vddhavaldholakiya1910@gmail.com |
|
|
Source of Monetary or Material Support
|
| P.D.Patel Ayurveda Hospital,
J.S. Ayurveda Mahavidyalaya Campus,
College road
Nadiad. |
|
|
Primary Sponsor
|
| Name |
J S Ayurveda Mahavidyalaya |
| Address |
J S Ayurveda Mahavidyalaya, College road, Nadiad |
| 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 Palak Singhal |
P D Patel Ayurveda Hospital |
Department of Kayachikitsa,
P D Patel Ayurveda Hospital,
J S Ayurveda Mahavidyalaya, College Road, Nadiad.
Kheda
GUJARAT |
9727716549
palaksinghal96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L409||Psoriasis, unspecified. Ayurveda Condition: PSORIASIS, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1 Lelitaka-Makshika Yoga processed with Amalaki Svarasa
2 Lelitaka-Makshika Yoga processed with Jatipatra Svarasa |
1 Lelitaka-Makshika Yoga processed with Amalaki Svarasa-2 tablets twice daily after meal
2 Lelitaka-Makshika Yoga processed with Jatipatra Svarasa- 2 tablets twice daily after meal |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who fulfill any three of the symptoms and any one of the signs mentioned in the diagnostic criteria.
2.Patients of age between 18 to 60 years and of both the gender.
Diagnostic criteria
Any three of the following Symptoms:
1. Scaling (Dalana)
2. Itching (Kandu)
3. Discoloration (Krsna Aruna Varna/ Abhrakapatrasama)
4. Loss of perspiration (Asvedanam)
5. Dryness (Rukshata)
6. Erythema
7. Lesions Distribution
Anyone of the following Signs:
8. Auspitz’s sign
9. Candle grease sign
10. Koebner’s phenomena
|
|
| ExclusionCriteria |
| Details |
1.Pregnant or lactating females
2.Patients who have taken medicine of corticosteroid drugs or immunosuppressants or other biological medicines within the last 6 months.
3.Patient with an associated disease like Hyper or Hypothyroidism, Diabetes mellitus,
Cardiovascular disorders, Liver disorder, Kidney disorders, Cancer.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in signs and symptoms of psoriasis. |
BASELINE AND AFTER 8 WEEKS. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/12/2020 |
| Date of Study Completion (India) |
11/01/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
11/01/2022 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NOT APPLICABLE. THIS THESIS WORK IS YET TO BE SUBMITTED. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The main aim of the study is clinical evaluation of ayurvedic management in psoriasis by Lelitaka-Makshika Yoga processed with Amalaki Svarasa and Lelitaka-Makshika Yoga processed with Jatipatra Svarasa. Patients will be selected from P. D. Patel Ayurvedic Hospital, Nadiad after the conformation of the patients of psoriasis with the help of its classical signs and symptoms. They will be treated with the following therapy 1. Lelitaka-Makshika Yoga processed with Amalaki Svarasa- 2 tablets twice daily after meal. 2.Lelitaka-Makshika Yoga processed with Jatipatra Svarasa-2 tablets twice daily after meal. Psoriasis is a chronic, non-communicable, recurrent, inflammatory, hyperproliferative skin disease. It is characterized by well-defined erythematous, dry plaques of various sizes covered with mica like scales. It particularly affects extensor surfaces and scalp, and usually follows a relapsing and remitting course. Psoriasis affects approximately 2.0% to 3.0% of the world’s population. Higher prevalence rates were found in western countries.The prevalence of Psoriasis in India is estimated to be between 0.44% and 2.8%.
Result: For all the signs and symptoms in the research work, the p-value is more than 0.05. Hence, acceptance of the tested null hypothesis is confirmed the and alternate hypothesis was rejected. In a two-sample unpaired t-test, comparing the effect of therapy, no significant difference in effect was found between the groups.
|