| CTRI Number |
CTRI/2020/11/028867 [Registered on: 03/11/2020] Trial Registered Prospectively |
| Last Modified On: |
31/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A STUDY TO ASSESS THE EFFECT OF AYURVEDIC TREATMENT IN THE BIOMARKER TNF-ALPHA IN PSORIASIS |
|
Scientific Title of Study
|
EFFECT OF SNEHAPANA AND VIRECHANA IN THE PROINFLAMMATORY BIOMARKER TNF-α IN PSORIASIS |
| Trial Acronym |
PASI |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neethi Rajan |
| Designation |
PG Scholar (Department of Agadatantra) |
| Affiliation |
Government Ayurveda College Thiruvananthapuram |
| Address |
Department of Agadatantra
Government Ayurveda College Thiruvananthapuram
Panchakarma Hospital Campus
Poojappura
Thiruvananthapuram
Thiruvananthapuram
KERALA
695012
India |
| Phone |
9400460781 |
| Fax |
|
| Email |
neethirajan150@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr C K Krishnan Nair |
| Designation |
Professor and HOD (Retd.) - Guide |
| Affiliation |
Government Ayurveda College Thiruvananthapuram |
| Address |
Department of Agadatantra
Government Ayurveda College Thiruvananthapuram
Panchakarma Hospital Campus
Poojappura
Thiruvananthapuram
Thiruvananthapuram
KERALA
695012
India |
| Phone |
9447260138 |
| Fax |
|
| Email |
krishnannairck@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neethi Rajan |
| Designation |
PG Scholar (Department of Agadatantra) |
| Affiliation |
Government Ayurveda College Thiruvananthapuram |
| Address |
Department of Agadatantra
Government Ayurveda College Thiruvananthapuram
Panchakarma Hospital Campus
Poojappura
Thiruvananthapuram
Thiruvananthapuram
KERALA
695012
India |
| Phone |
9400460781 |
| Fax |
|
| Email |
neethirajan150@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Agadatantra
Government Ayurveda College Thiruvananthapuram
Panchakarma Hospital Campus
Poojappura
PIN 695012 |
|
|
Primary Sponsor
|
| Name |
Dr Neethi Rajan |
| Address |
Department of Agadatantra
Government Ayurveda College Thiruvananthapuram
Panchakarma Hospital Campus
Poojappura
PIN 695012 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Neethi Rajan |
Government Ayurveda College Panchakarma Hospital |
OP No.3
Department of Agadatantra
Government Ayurveda College
Panchakarma Hospital Campus
Poojappura
Thiruvananthapuram
PIN 695012
Thiruvananthapuram
KERALA |
9400460781
neethirajan150@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE, Government Ayurveda College Thiruvananthapuram |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L400||Psoriasis vulgaris. Ayurveda Condition: EKAKUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Shaddharanam Choornam, Mahathikthakam Ghrtam, Psorset Oil, Vellaruku Tailam |
Shaddharanam Choornam 5gm at 8am and 4pm for 3days orally, Mahathikthakam Ghrtam at 6am for 7days orally, Psorset Oil quantity sufficient for external application, Vellaruku Tailam 15ml at 6am for 7days orally |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. External dryness
2. Itching
3. Scaling
4. Thickness
5. Erythematous patches
6. Well demarcated plaques of skin
7. Auspitz sign
8. Those who are willing to take part in the trial |
|
| ExclusionCriteria |
| Details |
1. Other autoimmune diseases
2. Infectious diseases
3. Multiple joint pain
4. Chronic systemic disorders or congenital disorders
5. Under steroid therapy
6. Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
TNF-α value
PASI SCORE |
Assessment of TNF-α will be done on 0th day, 19th day and on 45th day
PASI SCORE before and after treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Generalised well being of the patient |
45days |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
06/11/2020 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Psoriasis is a common, chronic inflammatory recurrent cutaneous auto immune disease. Patients with Psoriasis satisfying the inclusion and exclusion criteria will be included in the trial. The objective of the trial is to do the assessment of Psoriasis using the biomarker TNF-alpha and PASI Score after applying the Ayurvedic treatment modalities. The participants will be given 3days Amapachana with Shaddharanam Choorna, Snehapana for 7days with Mahathikthaka Ghrta, Abhyanga and Ushnodaka snana for 1day and Virechana with Vellaruku taila for 7days consecutively. Assessment of biological marker will be done on the day before Amapachana (0th day), after Virechana (19th day) and on the 45th day. Assessment of PASI score will be done on the basis of scoring criteria. |