| CTRI Number |
CTRI/2016/06/007035 [Registered on: 23/06/2016] Trial Registered Retrospectively |
| Last Modified On: |
20/06/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Treatment of ekkushtha(psoriasis)by virechana karma and shiravedhan |
|
Scientific Title of Study
|
Comparative Study To Evaluated The Efficacy Of Virechana Karma And Siravedhana In The Management Of Ekkushtha (Psoriasis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
jayesh odedra |
| Designation |
phd scholar |
| Affiliation |
Institute for Post Graduate Teaching and research in Ayurved |
| Address |
Institute for Post Graduate Teaching and research in Ayurved Department of Panchkarma IPGT and RA Jamnagar Gujarat Ayurved University Jamnagar GUJARAT
Jamnagar
GUJARAT
361001
India
Jamnagar
GUJARAT
361004
India |
| Phone |
9429563141 |
| Fax |
|
| Email |
drjayeshodedra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr anup B thakar |
| Designation |
Associate professor and Incharge head of department of Panchkarma |
| Affiliation |
Institute for Post Graduate Teaching and research in Ayurved |
| Address |
nstitute for Post Graduate Teaching and research in Ayurved Department of Panchkarma IPGT and RA Jamnagar Gujarat Ayurved University Jamnagar GUJARAT
Jamnagar
GUJARAT
361001
India
Jamnagar
GUJARAT
361001
India |
| Phone |
9427776660 |
| Fax |
|
| Email |
anup_thakar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
jayesh odedra |
| Designation |
phD scholar |
| Affiliation |
nstitute for Post Graduate Teaching and research in Ayurved |
| Address |
Institute for Post Graduate Teaching and research in Ayurved Department of Panchkarma IPGT and RA Jamnagar Gujarat Ayurved University Jamnagar GUJARAT
Jamnagar
GUJARAT
361001
India
Jamnagar
GUJARAT
361001
India |
| Phone |
9429563141 |
| Fax |
|
| Email |
drjayeshodedra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Post Graduate Teaching and research in Ayurved Gujarat ayurved university jamnagar
india
gujarat
jamnagar 361008
|
|
|
Primary Sponsor
|
| Name |
AYUSH department |
| Address |
MINISTRY OF AYUSH AYUSH BHAWAN, B Block, GPO Complex, INA, NEW DELHI - 110023 |
| 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 |
| Drjayesh odedra |
hospital of IPGT AND RA panchkarama department opd no 22 |
Institute for Post Graduate Teaching and research in Ayurved Department of Panchkarma IPGT and RA Jamnagar Gujarat Ayurved University Jamnagar GUJARAT
Jamnagar
GUJARAT
361001
India
Jamnagar
GUJARAT |
9429563141
drjayeshodedra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute for Post Graduate Teaching and research in Ayurved Gujarat ayurved university jamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients suffereing from psoriasis , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Manjisthadi kwath, kaishor guggulu, gandhaka rasayana, virechan karma with trikatu churna, triphala kashaya, trivrut kashaya, danti kashaya, goghrita, |
Manjisthadi kashaya contains Manjishtha Bakuchi Chakramarda Nimba Vasa Bala Shatavari Patola Rakta Chandana Haritaki Aamalaki Ushira Yashtimadhu, Kaishor guggulu contains triphala trivrut danti trikatu guggulu vidanga, Gandhaka rasayan contains shuddha gandhaka and Guduchi, Aamalaka, Bhrungaraja, Aadraka ,chaturjata virechan karma with haritaki amalaki bibhitaki danti trivrut shunthi marich pippali goghrita In group A classical Virechana Karma will be administered in virechana karma dipan pachana done by trikatu churna 2gm/ 3time for 3 to 5 days than snehpan will be done by shudha go ghrita for 5 to 7 days and than abhyanga and swedana done for 3 days, followed by Siravedhana will be done by scalp vein no 20 from medial cubital vein in the volume of 30-60 ml total 4 sitting will be day every 7 days for one month and then Manjishthadi kashaya 10ml bd for 1 month, Kaishor Gugglu 2tblet(each tablet 500mg) tds and Gandhaka Rasayana 2tblet(each tablet 500mg) tds will be given as a shamana for 1 month In group B classical Virechana Karma will be administered in virechana karma dipan pachana done by trikatu churna 2gm/ 3time for 3 to 5 days than snehpan will be done by shudha go ghrita for 5 to 7 days and than abhyanga and swedana done for 3 days and then Manjishthadi kashaya 10ml bd for 1 month Kaishor Gugglu 2tblet(each tablet 500mg) tds and Gandhaka Rasayana 2tblet(each tablet 500mg) tds will be given as a shamana for 1 month |
| Intervention |
Manjishthadi Kashaya, Kaishor guggulu, gandhaka rasayana, Virechana Karma,Shiravedha |
Manjisthadi kashaya contains Manjishtha Bakuchi Chakramarda Nimba Vasa Bala Shatavari Patola Rakta Chandana Haritaki Aamalaki Ushira Yashtimadhu, Kaishor guggulu contains triphala trivrut danti trikatu guggulu vidanga, Gandhaka rasayan contains shuddha gandhaka and Guduchi, Aamalaka, Bhrungaraja, Aadraka ,chaturjata virechan karma with haritaki amalaki bibhitaki danti trivrut shunthi marich pippali goghrita In group A classical Virechana Karma will be administered in virechana karma dipan pachana done by trikatu churna 2gm/ 3time for 3 to 5 days than snehpan will be done by shudha go ghrita for 5 to 7 days and than abhyanga and swedana done for 3 days, followed by Siravedhana will be done by scalp vein no 20 from medial cubital vein in the volume of 30-60 ml total 4 sitting will be day every 7 days for one month and then Manjishthadi kashaya 10ml bd for 1 month, Kaishor Gugglu 2tblet(each tablet 500mg) tds and Gandhaka Rasayana 2tblet(each tablet 500mg) tds will be given as a shamana for 1 month In group B classical Virechana Karma will be administered in virechana karma dipan pachana done by trikatu churna 2gm/ 3time for 3 to 5 days than snehpan will be done by shudha go ghrita for 5 to 7 days and than abhyanga and swedana done for 3 days and then Manjishthadi kashaya 10ml bd for 1 month Kaishor Gugglu 2tblet(each tablet 500mg) tds and Gandhaka Rasayana 2tblet(each tablet 500mg) tds will be given as a shamana for 1 month |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with all forms of Ekakushtha (Psoriasis) who are clinically fit to undergo Virechana and Shiravedhana |
|
| ExclusionCriteria |
| Details |
Patients who are clinically unfit for Virechana and Shiravedhana
Age 16yrs & 60yrs.
Pregnant women
Uncontrolled Diabetes Mellitus & Hypertension
Any other serious systemic illness
Chronicity more than 10 years
Patients who are not willing to be included in the study |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in signs and symptoms of psoriasis |
after 2 month of completion of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Efficacy and Safety |
after completion of 2 month of treatment |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
21/09/2015 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
In
this clinical trial total 64 patients were registered and randomly divided into
two groups. In group A Virechana karma foll·
In
this clinical trial total 64 patients were registered and randomly divided into
two groups. In group A Virechana karma followed by shaman yogas and in group B Virechana
followed by Siravedhana Karma and after that shaman yogas was given.
Among them 28 patients were completed the treatment in group A and 30 patients
were completed the treatment in group B. 4 patients left before completion of
treatment in group A and 2 patients in group B. After completion of treatment patients
Group A shows highly significant
(p<0.001) decrease in Mandala (Erythema) by 59.14%, Matsyashakalopama
(Scaling) by 51.78%, Rukshata (Dryness) by 54.25%, Aswedana (Anhydrosis)
by 58.1%, Daha (Burning sensation) by 56.67%, Bahalatva (Thickening
of skin lesion) by 47.36%, Kandu (Itching) by 56.00%, Srava(
discharge) by 54.56%, Dermatology
Life Quality Index (DLQI) by 56.57% and Psoriasis Area Severity Index (PASI)
score by 52.28% and in group B also
shows highly significant (p<0.001) decrease the Mandala (Erythema)
by 65.9%, Matsyashakalopama (Scaling) by 63.67%, Rukshata (Dryness)
by 60.24%, Aswedana (Anhydrosis) by 55.56%, Daha (Burning
sensation) by 65.35%, Bahalatva (Thickening of skin lesion) by 56.84%, Kandu
(Itching) by 65.51%, Srava( discharge) by 76.92% Dermatology Life Quality Index
(DLQI) by 62.24% and Psoriasis Area Severity Index (PASI) score by 55.19%.
In Overall Effect of Therapy Marked improvement was found in 3(10.00%) patients in
group B and 1(3.57%) patients in Group A. Moderate improvement was found in 20
(66.66%) patients in Group B and 17 (60.71%) patient in Group A.
In
the present study When Chi square – test was applied for comparison between
two groups there was not any significant difference found between two groups However
percent wise group B showed better results. |