| CTRI Number |
CTRI/2024/02/062405 [Registered on: 07/02/2024] Trial Registered Prospectively |
| Last Modified On: |
07/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Longitudinal observational |
| Study Design |
Other |
|
Public Title of Study
|
The change in antioxidant enzyme activity in Atopic Dermatitis patients undergoing Shodhana - A longitudinal observational study |
|
Scientific Title of Study
|
The change in Serum Superoxide Dismutase and Serum Catalase Enzyme Activity in Atopic Dermatitis patients undergoing Shodhana -A Longitudinal Observational 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 |
Pooja P J |
| Designation |
PG Scholar |
| Affiliation |
Amrita school of ayurveda |
| Address |
Amrita School of Ayurveda
Department of Panchakarma
Amritapuri
Clappana P O
Karunagapalli
Kollam , Kerala
Kollam
KERALA
690525
India |
| Phone |
9400483337 |
| Fax |
|
| Email |
pjpooja810@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K. Parameswaran Namboothiri |
| Designation |
Professor and Head of the Department |
| Affiliation |
Amrita school of ayurveda |
| Address |
Amrita School of Ayurveda
Department of Panchakarma
Amritapuri
Clappana P O
Karunagapalli
Kollam , Kerala , Pin-690525
Kollam
KERALA
690525
India |
| Phone |
9496096694 |
| Fax |
|
| Email |
kpn@ay.amrita.edu |
|
Details of Contact Person
Public Query
|
| Name |
Pooja P J |
| Designation |
PG Scholar |
| Affiliation |
Amrita school of ayurveda |
| Address |
Amrita School of Ayurveda
Department of Panchakarma
Amritapuri
Clappana P O
Karunagapalli
Kollam , Kerala , Pin-690525
Kollam
KERALA
690525
India |
| Phone |
9400483337 |
| Fax |
|
| Email |
pjpooja810@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita School of Ayurveda
Amritapuri
Clappana P O
Vallikavu
Karunagapalli
Kollam
PIN - 690525
|
|
|
Primary Sponsor
|
| Name |
Pooja P J |
| Address |
Amrita School of Ayurveda
Department of Panchakarma
Amritapuri
Clappana P O
Karunagapalli
Kollam , Kerala , Pin-690525 |
| 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 Pooja P J |
Amrita School of Ayurveda |
Panchakarma OP department
Kollam
KERALA |
9400483337
pjpooja810@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amrita Centre for Advanced Research in Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L209||Atopic dermatitis, unspecified. Ayurveda Condition: VICARCIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with HR criteria |
|
| ExclusionCriteria |
| Details |
Under medication
Vitamin supplementation
Any other systemic illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
ïƒ To identify change in serum SOD enzyme activity after shodhana in atopic dermatitis
ïƒ To identify change in serum CAT enzyme activity after shodhana in atopic dermatitis.
|
On the first day of deepana pachana and
On the day after shodhana
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To asses the change in severity of symptoms using SCORAD after shodhana.
|
On the first day of deepana pachana & On the day after shodhana |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
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)
|
11/03/2024 |
| 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)
|
Open to Recruitment |
| 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
|
The patients undergoing shodhana satisfying the inclusion criteria
will be observed for the study.
INCLUSION CRITERIA - 18 to 30 years , Irrespective of gender , Diagnosed with Hanifin Rajka criteria EXCLUSION CRITERIA - Under medication , Vitamin supplementation , Any other systemic illness
|