| CTRI Number |
CTRI/2017/08/009495 [Registered on: 25/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
22/06/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
CLINICAL STUDY ON NISHOTHAMADI GHANA VATI
AND BRUHAT DANTAPALA TAILA IN THE MANAGEMENT OF PSORIASIS |
|
Scientific Title of Study
|
CLINICAL STUDY ON EFFECTIVENESS OF NISHOTHAMADI GHANA VATI
AND BRUHAT DANTAPALA TAILA IN THE MANAGEMENT OF EKA KUSTHA (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 Yadu narayanan Mooss E T |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheswara college of ayurveda and hospital |
| Address |
Department of kayachikitsa
Shri Dharmasthala Manjunatheswara college of ayurveda and hospital
Hassan
Shri Dharmasthala Manjunatheswara college of ayurveda and hospital
Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
09895077090 |
| Fax |
|
| Email |
yadu.mooss@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Girish K J |
| Designation |
Professor |
| Affiliation |
Shri Dharmasthala Manjunatheswara college of ayurveda and hospital Hassan |
| Address |
Department of kayachikitsa
Shri Dharmasthala Manjunatheswara college of ayurveda and hospital
Hassan
Department of kayachikitsa
Shri Dharmasthala Manjunatheswara college of ayurveda and hospital
Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9448646866 |
| Fax |
|
| Email |
drgirishkj@sdmcahhassan.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Girish K J |
| Designation |
Professor |
| Affiliation |
Shri Dharmasthala Manjunatheswara college of ayurveda and hospital Hassan |
| Address |
Department of kayachikitsa
Shri Dharmasthala Manjunatheswara college of ayurveda and hospital
Hassan
Department of kayachikitsa
Shri Dharmasthala Manjunatheswara college of ayurveda and hospital
Hassan
Raichur
KARNATAKA
573201
India |
| Phone |
9448646866 |
| Fax |
|
| Email |
drgirishkj@sdmcahhassan.org |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara
College of Ayurveda & Hospital
BM Road Thanniruhalla Hassan-573201
Karnataka |
|
|
Primary Sponsor
|
| Name |
Shri Dharmasthala manjunatheswara college of ayurveda and hospitalhassan |
| Address |
Shri Dharmasthala manjunatheswara college of ayurveda and hospital,
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 Yadu narayanan Mooss |
Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital, |
BM ROAD
Thanniruhalla
Hassan-573201
Hassan
KARNATAKA |
9895077090
yadu.mooss@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ekakushta (psoriasis), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bruhat Danatapala tailam |
local application twice daily |
| Comparator Agent |
nil |
nil |
| Intervention |
Nishottamadi Ghanavati |
500 mg 4 tid |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with the lakshanas of Eka Kustha as explained in classical texts.
Patients of either gender, between the age of 16 to 60 years .
Patients who are ready to sign informed consent form. |
|
| ExclusionCriteria |
| Details |
Psoriasis with extracutaneous manifestations like psoriatic arthritis will be excluded.
Diagnosed Patients of uncontrolled Diabetes mellitus, tuberculosis will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
SUBJECTIVE CRITERIA
ï‚· Aswedana(anhydrosis)
30 DAYS
OBJECTIVE CRITERIA
 Mahavastum (area of involvement is vast)
 Matsyashakalopam (Fish like scale)
 Erythema
 Induration
 Desquamation
 Positive Auspitz Sign
 Positive Candle Grease Test
 Koebner’s Phenomenon.
30 DAYS |
SUBJECTIVE CRITERIA
ï‚· Aswedana(anhydrosis)
30 DAYS
OBJECTIVE CRITERIA
 Mahavastum (area of involvement is vast)
 Matsyashakalopam (Fish like scale)
 Erythema
 Induration
 Desquamation
 Positive Auspitz Sign
 Positive Candle Grease Test
 Koebner’s Phenomenon.
30 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
22/04/2016 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
SUMMARY CLINICAL STUDY ON EFFECTIVENESS OF NISHOTHAMADI GHANA VATI AND BRUHAT DANTAPALA TAILA IN THE MANAGEMENT OF EKA KUSTHA (PSORIASIS)
Socio-psychological impacts, limitations of modern medicine and recurrence make psoriasis a burning problem among the skin diseases. It is universal in occurrence and the incidence rate is 1-3% of the population worldwide. In India overall incidence of Psoriasis is 1.02%. Traditional practitioners of Kerala have been using a combination of Nishothamadi Kashaya and Bruhat Dantapala Taila in the management of Eka Kustha without opting for sodhana procedures.
Eka Kustha is one among kshudra kusthas, with a predominance of Vata&Kapha. This is an effort to document systematically and validate the effect of this combination in managing Eka kustha. Instead of Nishothamadi kashaya, Nishothamadi Ghanavati which is the concentrated form of kashaya (3) is selected because of its easy mode of administration as well as increased shelf life.
The current study will be an open labeled single arm exploratory clinical trial with pre and post test design in Eka kustha(psoriasis) conducted in SDM Ayurveda hospital, Hassan. Total Sample size - 30 patients All the patients who fit in inclusion criteria will be given with
A) Nishothamadi Ghana vati internally - Ghanavati will be given in dosage of 4 tablets thrice daily(each 500 mg) with anupana of luke warm water for 30 days.
B) Bruhat dantapala taila externally – Taila will be applied on the lesion twice daily after bath for 30 days.
Follow up during treatment will be done on15 th and 30 th day during treatment and 15 th day after treatment to know whether the relief provided by the drugs is sustained. Collected data will be tabulated and analysed using SPSS (Statistical package for social sciences) version 20 and using appropriate statistical tests. |