| CTRI Number |
CTRI/2016/02/006631 [Registered on: 11/02/2016] Trial Registered Retrospectively |
| Last Modified On: |
19/01/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to evaluate the efficacy and safety of the Vamana karma followed with two Rasayanas Takradhara and Rasaoushadi in treatment of psoriasis. |
|
Scientific Title of Study
|
Evaluation of clinical efficacy and safety of the Vamana karma followed by Takradhara and Rasaushadhi rasayana chikitsa in 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 P Radhakrishnan |
| Designation |
Research Officer (SCT 4) |
| Affiliation |
National Research Institute for Panchakarma |
| Address |
National Research Institute for Panchakarma Cheruthuruthy
Thrissur
KERALA
679531
India |
| Phone |
9495025380 |
| Fax |
04884-262366 |
| Email |
dr.radhakrishnancrip@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Radhakrishnan |
| Designation |
Research Officer (SCT 4) |
| Affiliation |
National Research Institute for Panchakarma |
| Address |
National Research Institute for Panchakarma Cheruthuruthy
Thrissur
KERALA
679531
India |
| Phone |
9495025380 |
| Fax |
04884-262366 |
| Email |
dr.radhakrishnancrip@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P Radhakrishnan |
| Designation |
Research Officer (SCT 4) |
| Affiliation |
National Research Institute for Panchakarma |
| Address |
National Research Institute for Panchakarma Cheruthuruthy
Thrissur
KERALA
679531
India |
| Phone |
9495025380 |
| Fax |
04884-262366 |
| Email |
dr.radhakrishnancrip@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Central council for Research in Ayurvedic sciences CCRAS |
| Address |
Central council for Research in Ayurvedic sciences
Department of AYUSH
Ministry of Health & Family Welfare, Government of India
61-65, Institutional Area, opposite "D" Block, Janakpuri
new Delhi-110058 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Achintya Mitra |
NRIADD Kolkata |
National Research Institute for Ayurvedic Drug Development
Kolkata
Kolkata
WEST BENGAL |
9836727927
achintyamitra1@gmail.com |
| Dr P Radhakrishnan |
NRIP Cheruthuruthy |
National Research Institute for Panchakarma Cheruthuruthy
Thrissur
Kerala 679531
Thrissur
KERALA |
9495025380
04884-262366
dr.radhakrishnancrip@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee NRIADD, Kolkatta |
Approved |
| Institutional Ethics Committee NRIP Cheruthuruthy |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Psoriasis (Kitibha), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Vamana karma followed by oral administration of Yashad Bhasma along with Triphala churna |
Mahatiktaka Ghrita (30 g, 60g, 90gm etc) in increased dose manner for 7 days
Madanphalamajja churna- 10gm
Yashtimadhu churna- 5gm
Saindhava Lavana- 5gm
Madhu- 15ml
Vacha Churna- 5 gm
Yashtimadhu kwatha- 100 ml(from 50 gm kwatha churna)
Milk -2 ltr
Samsarjanakarma
Amla (Yavakuta churna)- 400gm for decoction
Musthak (yavakuta Churna)- 100gm boiled in milk- 1.5 liter added with curd-100ml are to be used for Takradhara for 45 minutes upto 7 days.
Rasayana therapy (4 weeks)
Yasadha bhasma 100 mg (into two divided doses)
Triphala Churna- 3 g
Follow Up
Yasadha bhasma 100 mg (into two divided doses)
Triphala Churna- 3 g
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of either sex with age between 18 and 60 years
2.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)
3.Patients suffering from psoriasis with less than 50 % of the body surface involvement
4.Patients having less than 10 years duration of disease
5.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 or Pustular or Erythrodermic or inverse.
3.Patients suffering from very severe psoriasis with more than 50% of the body surface involvement
4.Patients having chronic disease i.e. more than 10 years duration
5.Patients who are not ready for IPD admission or Vamana Karma or follow up as specified
6.Patients with Psoriatic arthropathy
7.Patients with poorly controlled Hypertension ( more than 160/100 mmHg)
8.Patients with poorly controlled Diabetes Mellitus having Hb A1C of greater than 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.Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) more than 2 times upper normal limit) or Renal Disorders (defined as S. Creatinine more than 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.
13.Alcoholics and/or drug abusers
14.H/o hypersensitivity to any of the trial drugs or their ingredients
15.Pregnant/lactating woman.
16.Patients who have completed participation in any other clinical trial during the past six months.
17.Other conditions which are of contraindications for Vamana karma
18.Any other condition which the Investigator thinks may jeopardize the study.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in signs and symptoms (change in baseline in Plaque psoriasis) Reduction in psoriasis area and severity index (PASI) Score, PASI 50 (50% improvement in PASI Score) |
At Baseline, 24th day, 45th day and 66th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Relief in signs and 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.
Any improvement in Hamilton’s anxiety scale.
|
At baseline, 24th day, 45th day and 66th day |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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 3 |
|
Date of First Enrollment (India)
|
27/10/2013 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This is a part of Intra Mural Clinical Research Programme of the council for Research in Ayurvedic Sciences (CCRAS), Department of AYUSH, Ministry and Health and Family Welfare, Govt. Of India, incorporating vamanakarma as samsodhana karma Followed by Takradhara and rasayana chikitsa with yasada Bhasma with a view to scientifically document the clinical efficacy and safety of the said Ayurvedic formulations that have been in use since thousands of years for the management of Kitibha (psoriasis). |