| CTRI Number |
CTRI/2014/09/005058 [Registered on: 25/09/2014] Trial Registered Retrospectively |
| Last Modified On: |
06/11/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic clinical study for the management of Psoriasis |
|
Scientific Title of Study
|
Clinical Evaluation of Vajraka Ghrita, Arogyavardhini Vati and Dineshavalyadi Taila in the Management of Kitibha (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 Maheswar Thugutla |
| Designation |
Research Officer (Ayurveda) |
| Affiliation |
National Ayurveda Research Institute for Vector Borne Diseases |
| Address |
National Ayurveda Research Institute for Vector Borne Diseases, New Rajeev Nagar, Payakapuram, Vijayawada.
Krishna
ANDHRA PRADESH
520015
India |
| Phone |
9441415266 |
| Fax |
08662402144 |
| Email |
mahesh_rri@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Kumara Swamy |
| Designation |
Assistant Director in charge |
| Affiliation |
Centra Council for Research in Ayurvedic Sciences |
| Address |
National Ayurveda Research Institute for Vector Borne Diseases
New Rajivnagar
Payakapuram
Vijayawada
Krishna
ANDHRA PRADESH
520015
India |
| Phone |
8500064848 |
| Fax |
08662402144 |
| Email |
narivbd.vijayawada@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Kumara Swamy |
| Designation |
Assistant Director in charge |
| Affiliation |
Centra Council for Research in Ayurvedic Sciences |
| Address |
National Ayurveda Research Institute for Vector Borne Diseases
New Rajivnagar
Payakapuram
Vijayawada
Krishna
ANDHRA PRADESH
520015
India |
| Phone |
8500064848 |
| Fax |
08662402144 |
| Email |
narivbd.vijayawada@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurvedic Sciences |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Ayurvedic Sciences |
| Address |
Central Council for Research in Ayurvedic Sciences,JLNBCEH Anusandhan Bhavan No 61-65, Institutional Area, Opp.D Block, Janakpuri,New Delhi |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrHemanta Panigrahi |
Ayurvedic Central Research Institute |
Road Number - 66, Punjabi Bagh, New Delhi- 110026.
New Delhi
DELHI |
9968074400
drhemanta@sify.com |
| DrMaheswar Thugutla |
National Ayurveda Research Institute for Vector Borne Diseases |
New Rajeev Nagar,
Payakapuram,
Vijayawada
Krishna
ANDHRA PRADESH |
9441415266
08662402144
mahesh_rri@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, ACRI, New Delhi |
Approved |
| Institutional Ethical Committee, NARIVBD,Vijayawada |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Psoriasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
Vajraka Ghrita,Arogyavardhini vati,Dineshavalyadi taila |
Vajraka Ghrita 6gm twice daily with luke warm water - 12 weeks
2.Arogyavardhini vati 250mg twice daily - 12 weeks
3.Dineshavalyadi taila 20ml twice daily for external application for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Known cases of psoriasis, without psoriatic arthropathy,
Exhibiting psoriatic triad –
I.Bright pink or red lesions with pronounced edges, covered with silvery white scales, the scales can be easily separated from the lesion
II.Under the scales there appears a pinkish moist tender skin
III.With the scarping of the moist skin there appear tiny blood droplets (Auspitz’s sign)
2.Patients suffering from mild to moderate psoriasis with less than 50 % of the body surface involvement
3.Patients having less than 10 years duration
4.Positive histopathological finding.(Skin-biopsy - optional)
|
|
| ExclusionCriteria |
| Details |
1.Age below 18 years and above 60 years
2.Patients with other forms of Psoriasis like Guttate/ Pustular/ Erythrodermic/ inverse.
3.Patients suffering from severe psoriasis with more than 50% of the body surface involvement
4.Patients having chronic disease i.e. more than10 years duration
5.Patients who cannot report in person every 2 weeks in the OPD
6.Patients with Psoriatic arthropathy
7.Patients with poorly controlled Hypertension ( >160/100 mmHg)
8.Patients with poorly controlled Diabetes Mellitus having Hb A1C of > 7.5%
9.Patients on medication with corticosteroids, phototherapy, biologics, antidepressants any other drugs that may have an influence on the outcome of the study.
10.Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
11.Symptomatic patient with clinical evidence of Heart failure.
12.Known HIV positive cases
13.Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) > 2 times upper normal limit) or Renal Disorders (defined as S. Creatinine >1.2mg/dL), Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]), or any other condition that may jeopardize the study.
14.Alcoholics and/or drug abusers
15.H/o hypersensitivity to any of the trial drugs or their ingredients
16. Pregnant/lactating woman.
17.Patients who have completed participation in any other clinical trial during the past six months.
18.Any other condition which the Investigator thinks may jeopardize the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| •Relief in Signs & Symptoms (Change in baseline in plaque psoriasis) of the disease by Reduction in Psoriasis Area and Severity Index (PASI) Score, PASI 50 (50% improvement in PASI score) |
12 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Relief in Signs & Symptoms (Change in baseline in plaque psoriasis) of PASI 25.
•Improvement in Dermatology Life Quality Index (DLQI) Questionnaire.
•Any adverse drug reaction or event noted during the trial |
12 Weeks |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
26/09/2013 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
To be published after completion of the study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is aiming in generating the evidence for the scientific validation of the clinical efficacy and safety of classical Ayurvedic formulations a multi centric clinical trial has been initiated in psoriasis at 2 Institutes of Central Council for Research in Ayurvedic Sciences as an activity under Intra Mural Clinical Research Programme. Ayurvedic medicines Vajraka ghrita 6 gm twice daily, Arogyavardhini vati 250 mg twice daily and Dineshavalyadi taila 20 ml twice daily for external application will be given for 12 weeks in 120 patients of Psoriasis. This study will be conducted in 2 centres in India and completed in 3 years duration . The primary outcome measures will be relief in Signs & Symptoms (Change in baseline in plaque psoriasis) of the disease by Reduction in Psoriasis Area and Severity Index (PASI) Score, PASI 50 (50% improvement in PASI score). Secondary outcomes will be Relief in Signs & Symptoms (Change in baseline in plaque psoriasis) of PASI 25. Improvement in Dermatology Life Quality Index (DLQI) Questionnaire.
Compostion of Drugs:
1. Composition of Vajaraka Ghrita: Vasa - Adhatoda Vasaka, Guduchi - Tinospora cordifolia |