| CTRI Number |
CTRI/2021/02/031318 [Registered on: 16/02/2021] Trial Registered Prospectively |
| Last Modified On: |
15/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A research study to evaluate the effectiveness of panchanimbakam churna tablet and pathyadi lepa(Ayurvedic ointment) in psoriasis disease |
|
Scientific Title of Study
|
AN OPEN LABEL SINGLE ARM CLINICAL STUDY ON COMBINED
THE COMBINED EFFECTIVENESS OF PANCHANIMBAKAM
CHURNA VATI AND PATHYADI LEPA IN KITIBA KUSHTA
(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 Kalpana |
| Designation |
Md scholar department of Kayachikitsa |
| Affiliation |
SDM College of Ayurveda Hassan |
| Address |
Opd no 7, Kayachikitsa Department, SDM College of Ayurveda Thanniruhalla Hassan 573201
Opd no 7, Kayachikitsa Department, SDM College of Ayurveda Thanniruhalla Hassan 573201
Hassan
KARNATAKA
573201
India |
| Phone |
9686814628 |
| Fax |
|
| Email |
kalpanabhamini@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lakshmiprasad L Jadhav |
| Designation |
Head of department and Professor, Department of Kayachikitsa |
| Affiliation |
SDM College of Ayurveda Hassan |
| Address |
Opd no 4 SDM College of Ayurveda Thanniruhalla Hassan 573201
Opd no 4 SDM College of Ayurveda Thanniruhalla Hassan 573201
Hassan
KARNATAKA
573201
India |
| Phone |
9886614116 |
| Fax |
|
| Email |
sooryajadhav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalpana |
| Designation |
Md scholar department of Kayachikitsa |
| Affiliation |
SDM College of Ayurveda Hassan |
| Address |
Opd no 7 SDM College of Ayurveda Thanniruhalla Hassan 573201
Opd no 7 SDM College of Ayurveda Thanniruhalla Hassan 573201
Hassan
KARNATAKA
573201
India |
| Phone |
9686814628 |
| Fax |
|
| Email |
kalpanabhamini@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM College of Ayurveda and Hospital, BM Road Thanniruhalla, Hassan, Karnataka, Phone-8172256460 email- college@sdmcahhassan.org |
|
|
Primary Sponsor
|
| Name |
SDM College of Ayurveda Hassan |
| Address |
SDM College of Ayurveda bm road Thanniruhalla Hassan |
| Type of Sponsor |
Private medical college |
|
|
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 Kalpana |
SDM College of Ayurveda and Hospital, Hassan |
OPD 7, DEPARTMENT OF KAYACHIKITSA,BM ROAD THANNIRUHALLA
HASSAN
KARNATAKA
Hassan
KARNATAKA |
9686814628
pg19130@sdmcahhassan.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL HASSAN |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O||Medical and Surgical. Ayurveda Condition: KITIBAH, (2) ICD-10 Condition:L409||Psoriasis, unspecified. Ayurveda Condition: KITIBAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
N/A |
N/A |
| Intervention |
Panchanimbakam Churna vati
|
500mg (2 tablets) thrice daily, after food for a period of 30days.
|
| Intervention |
Pathyadi Lepa |
Mixed with water and applied in the thickness of one fourth of the finger in day time
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering with Kitibha Kushta <5years of chronicity.
2. Patients of either gender, aged between 18-60 years.
[10]
3. Patient willing to participate in the study and ready to sign informed consent form |
|
| ExclusionCriteria |
| Details |
Patients with systemic illness such as impaired cardiac, renal and hepatic
functions.
2. Metabolic disorders namely diabetes mellitus type 2 and essential
hypertension.
3. Pregnant women and lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in the PASI scale and symptoms of Kitibha Kushta |
outcomes will be assessed at baseline, 15 days and 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PASI scale |
15 days and 30 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
22/02/2021 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is an open label single arm prospective clinical study to assess the effectiveness of panchanimbakam churna vati and pathyadi lepa in management of kitibha kushta within age group of 18 to 60 for 30 days in 30 patients. The study will be conducted in one center in India. Secondary outcomes will be assessed by Pasi scale after 30 days |