CTRI/2024/06/068944 [Registered on: 14/06/2024] Trial Registered Prospectively
Last Modified On:
13/06/2024
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Drug Ayurveda
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Study on the efficacy of Guduchi Ghrita internally in the dose of 30ml in the morning along with Nalpamaradi taila as an external application in the management of Plaque psoriasis in adults age group of 18 to 60 years for a period of 30 days
Scientific Title of Study
Clinical study on the efficacy of Guduchi Ghrita as shamananga snehapana in the management of Ekakushta (Plaque Psoriasis): A controlled clinical study
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Pooja Prakash Chougala
Designation
Post Graduate Scholar
Affiliation
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital ,Bangalore
Address
Dept of Kayachikitsa OPD No.1,2,3,18,27 Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, SH 17 Anchepalya, Kumbalagodu post, Bangalore- 560074, Karnataka, India
Bangalore KARNATAKA 560074 India
Phone
9148168306
Fax
Email
drpoojac@sdmayurbangalore.in
Details of Contact Person Scientific Query
Name
Dr Mahesh Sharma M
Designation
Associate Professor
Affiliation
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital ,Bangalore
Address
Dept of Kayachikitsa OPD No-01 Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, SH 17 Anchepalya, Kumbalagodu post, Bangalore- 560074, Karnataka, India
Bangalore KARNATAKA 560074 India
Phone
9964022654
Fax
Email
drsharmamysr@gmail.com
Details of Contact Person Public Query
Name
Dr Pooja Prakash Chougala
Designation
Post Graduate Scholar
Affiliation
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital ,Bangalore
Address
Dept of Kayachikitsa OPD No.1,2,3,18,27 Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, SH 17 Anchepalya, Kumbalagodu post, Bangalore- 560074, Karnataka, India
Bangalore KARNATAKA 560074 India
Phone
9148168306
Fax
Email
drpoojac@sdmayurbangalore.in
Source of Monetary or Material Support
Dept of Kayachikitsa OPD No.1,2,3,18,27 Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, SH 17 Anchepalya, Kumbalagodu post, Bangalore- 560074, Karnataka, India
Primary Sponsor
Name
Dr Pooja Prakash Chougala
Address
Dept of Kayachikitsa OPD No.1,2,3,18,27 Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, SH 17 Anchepalya, Kumbalagodu post, Bangalore- 560074, Karnataka, India
Type of Sponsor
Other [Self ]
Details of Secondary Sponsor
Name
Address
Nil
Nil
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Pooja Prakash Chougala
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bangalore
Dept of Kayachikitsa
OPD No.1,2,3,18,27
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, SH 17 Anchepalya, Kumbalagodu post, Bangalore- 560074, Karnataka, India Bangalore KARNATAKA
9148168306
drpoojac@sdmayurbangalore.in
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Institutional Ethics Committee Shri Dharmasthala Manjunatheshwara Ayurveda and Hospital
1.Patient of age group 18 to 60 years fulfilling diagnostic criteria.
2.Patients irrespective of gender ,religion, socioeconomic status,
3.Patients with clinical features of Ekakushta or Plaque psoriasis
ExclusionCriteria
Details
1.Subjects those who are unfit for Snehapana.
2.Subjects with Uncontrolled Diabetes mellitus, Uncontrolled Hypertension, Psoriatic arthritis.
3.Subjects suffering from Chronic systemic illness which may interfere with the intervention.
4.Pregnant and Lactating Women.
5.Subjects age below 18 and above 60 years.
6.Subjects with Psoriasis having secondary severe infections.
7.Subjects with other than Plaque psoriasis.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Sequentially numbered, sealed, opaque envelopes
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Reduction in the clinical signs and Symptoms of Ekakushta based on
1.Psoriasis area and Severity index score
Oth day (Baseline),15th day,30th day and 45th day
Secondary Outcome
Outcome
TimePoints
Significant improvement noticed in the Quality of life of patient and reduction in signs and symptoms of Ekakushta based on Dermatological quality of life questionnaire
Baseline,15th day,30th day and 45th day
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)
25/06/2024
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="6" Days="0"
Recruitment Status of Trial (Global)
Not Yet Recruiting
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
A controlled
clinical study on the efficacy of Guduchi ghrita as shamananga snehapana in the
management of Ekakushta (Plaque Psoriasis) in adults of age group 18-60 years
for a period of 30 days. During this study period 30 subjects diagnosed with
Ekakushta (Plaque Psoriasis) will be recruited and divided into two groups,
Group A (Trial drug/Intervention group) and Group B (Control drug/Comparator
group)15 subjects in each group respectively. Group A (Trial drug/Intervention
group) it includes 15 subjects qualifying inclusion criteria of the current
study will be administered Guduchi ghrita internally as shamananga snehapana in
the dose of 30ml in the morning 20mins before breakfast followed by ushnajala
pana along with Nalpamaradi taila as an external application for 30days
starting from day-01 of trial, assessment of the patient during trial on 0th
day(baseline), 15th day, 30th day and after trial on 45th day. Group B (Control
Drug/Comparator Group) it includes 15 subjects qualifying inclusion criteria of
the current study will be administered Panchatiktaka guggulu ghrita internally
as shamananga snehapana in the dose of 30ml in the morning 20mins before
breakfast followed by ushnajala pana along with Nalpamaradi taila as an
external application for 30days starting from day-01 of trial, assessment of
the patient during trial on 0th day(baseline), 15th day, 30th day and after
trial on 45th day. The primary outcome measure will be significant improvement
noticed in Psoriasis area and severity index score (PASI) of Psoriasis after 30
days. The secondary outcome measure will be improvement noticed in the quality
of life of the patient through Dermatological quality of life questionnaire
after 30 days. Statistical analysis will be done through data obtained based
on, before and after treatment assessment.