| CTRI Number |
CTRI/2018/12/016594 [Registered on: 11/12/2018] Trial Registered Prospectively |
| Last Modified On: |
24/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
MANAGEMENT OF PSORIASIS WITH AYURVEDA FORMULATION |
|
Scientific Title of Study
|
CLINICO COMPARATIVE STUDY OF LELĪTAKA-MĀKṢIKA YOGA AND KAIŚORA GUGGULU -MAÑJIṢṬHĀDI KVĀTHA IN THE MANAGEMENT OF EKAKUṢṬA (PSORIASIS) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VIGNA RAJENDRABHAI VYAS |
| Designation |
PG SCHOLAR |
| Affiliation |
J S AYURVEDA MAHAVIDYALAYA |
| Address |
COLLEGE ROAD, NADIAD
Kheda
GUJARAT
387001
India |
| Phone |
8469908928 |
| Fax |
|
| Email |
vignavyas777@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF DR MANISH V PATEL |
| Designation |
PROFESSOR |
| Affiliation |
J S AYURVED MAHAVIDYALAYA |
| Address |
COLLEGE ROAD, NADIAD
Kheda
GUJARAT
387001
India |
| Phone |
9979589865 |
| Fax |
|
| Email |
manishayu97@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
VIGNA RAJENDRABHAI VYAS |
| Designation |
PG SCHOLAR |
| Affiliation |
J S AYURVEDA MAHAVIDYALAYA |
| Address |
COLLEGE ROAD, NADIAD
Kheda
GUJARAT
387001
India |
| Phone |
8469908928 |
| Fax |
|
| Email |
vignavyas777@gmail.com |
|
|
Source of Monetary or Material Support
|
| SUNDAR AYURVEDA TEACHING PHARMACY OF J S AYURVEDA COLLEGE, NADIAD |
|
|
Primary Sponsor
|
| Name |
J S AYURVED MAHAVIDYALAYA |
| Address |
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 Vigna R Vyas |
P D Patel Ayurveda Hospital |
PG Department
Kaychikitsa devision
Room no. 1 P D Patel
Ayurved hospital J S
Ayurveda college
campus college Road
Nadiad-387001
Kheda
GUJARAT |
8469908928
02682520646
vignavyas777@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for research project |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
KAISHORA GUGGULU TABLET AND MAJISTHADI KVATHA |
KAISHORA GUGGULU 3 TABLET (EACH 300 MG TABLETS) 3 TIMES IN A DAY WITH MANJISTHADI KVATHA 40 ML. |
| Intervention |
LELITAK MAKSHIK YOGA |
IT IS IN TABLET FORM OF 500 MG EACH TABLET. DOSE OF IT WILL BE OF 1 GM TWO TIMES IN A DAY WITH WATER |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Asvedana (loss of perspiration)
2. Mahavastu / Mandala (lesions distibution)
3. Matsyasakalopama (Scaling)
4. Krsna aruna varna / Abhrakpatrasama (Discoloration)
5. Kandu (Itching)
6. Ruksata (Dryness)
Following any one of this sign
1. Auspitz,s sign
2. Candle grease sign
3. Koebner,s phenomenon
|
|
| ExclusionCriteria |
| Details |
1. Female patients have pregnancy or lactating period.
2. Patient with associated disease like cardiovascular disorders, hyperthyroidism or hypothyroidism, cancer, tuberculosis, heart diseases, psoriatic arthritis, kidney and liver disorders.
3. Patients having HbA1c above 7.5 of diabetes mellitus.
4. Patients who have taken medication of corticosteroids, drugs within last 6 months.
|
|
|
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 |
8 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
PSORIASIS AREA AND SEVERITY INDEX
DERMATOLOGY QUALITY LIFE INDEX |
O DAY, 4WEEKS AND 8 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
15/12/2018 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
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
|
THIS WILL BE SUBMITTED IN A FORM OF DISSERTATION AND MAY PUBLISHED IN ANY PEER REVIEW JOURNAL WITH PRIOR PERMISSION OF GUJARAT AYURVEDA UNIVERSITY. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is randomized prospective interventional clinical study performed at P.D. Patel Ayurveda hospital, Nadiad, Gujrat. Total 37 patients were registered among them 30 patients were completed the treatment and 7 patients discontinued the treatment. 30 patients were equally divided in 2 group through computer generated block randomize method, 15 patients in each group. All the patients were treated with following schedule: Patients of group A were treated with lelÄ«taka mÄká¹£ika yoga tablet has given 2 tablets twice in a day meal for 8 weeks. Patients of group B were treated with kaiÅ›ora guggulu has given 3 tablets thrice in a day and mañjiá¹£á¹hÄdi kvÄtha has given 40 ml twice in a day at empty stomach. Patients were assessed by grade score symptomatically before and after completion of treatment. PASI was calculated with online calculator. DLQI was assessed with questionnaire. The study result was statistically analyzed by using the un-paired ‘t’ test. A value of p<0.05 was considered as statistically significant. LelÄ«taka-mÄká¹£ika yoga was take easily by every patient. Both medications are useful in dermatological disorders. LelÄ«taka-mÄká¹£ika yoga vaá¹i is more effective in compared kaiÅ›ora guggulu and mañjiá¹£á¹hÄdi kvÄtha. |