| CTRI Number |
CTRI/2023/07/055420 [Registered on: 20/07/2023] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
Modification(s)
|
Evaluation of herbal formulation in contact dermatitis |
|
Scientific Title of Study
|
Clinical evaluation of herbal formulation in Mild to Moderate Contact Dermatitis |
| 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 Kshipra Rajoria |
| Designation |
Assistant Professor (senior) |
| Affiliation |
National Institute of Ayurveda |
| Address |
Room no.115C,Department of Panchakarma,National Institute of Ayurveda,
Jorawer singh gate, Amer road,Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9001454100 |
| Fax |
|
| Email |
kshiprarajoria@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarvesh Kumar Singh |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
oom no.113A,Department of Panchakarma,National Institute of Ayurveda,
Jorawer singh gate, Amer road,Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8739860237 |
| Fax |
|
| Email |
sarveshksingh21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarvesh Kumar Singh |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
oom no.113A,Department of Panchakarma,National Institute of Ayurveda,
Jorawer singh gate, Amer road,Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8739860237 |
| Fax |
|
| Email |
sarveshksingh21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Plant Ayu Life Sciences LLP Pune |
|
|
Primary Sponsor
|
| Name |
Plant Ayu Life Sciences LLP Pune |
| Address |
A1-301, Wonderwall, Concord Portia Lane
Balewadi, Pune - 411045, Maharashtra, India
Email - plantayu@gmail.com
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Sarvesh Kumar Singh |
National Institute Of Ayurveda |
Room no.113C,department of Panchakarma,National Institute of Ayurveda,Jorawar Singh, Gate ,Jaipur
Jaipur
RAJASTHAN |
8739860237
sarveshksingh21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee National institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L259||Unspecified contact dermatitis, unspecified cause. Ayurveda Condition: VICARCIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: ECZ-Cream-01, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: ECZ-cream-02, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age from 18 - 60 yrs
2. Mild to moderate SCORing Atopic Dermatitis (SCORAD) > 5 % for > 1 months
3. Body surface involvement (BSI) of > 5%
4. Male or female
5. Willing to provide voluntary written informed consent.
|
|
| ExclusionCriteria |
| Details |
1) Pregnant women and lactating mothers.
2) Patients suffering from systemic disorders as Cardiac, renal and hepatic diseases, Uncontrolled Diabetes mellitus, Uncontrolled Hypertension, Paralysis, Malignancy, Human immune deficiency virus infection, HBsAg, Leprosy.
3) Patients suffering from Psoriatic arthritis.
4) Patients who have received systemic therapy for psoriasis or those who have been treated with immunosuppressive immune - modulating treatment in previous 8 weeks.
5) Patient with personal or family history of malignant or premalignant skin tumours.
6) Subject with active infection either acute or chronic by fungi, viruses bacteria and parasites
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of the study is to evaluate the changes in SCORing Atopic Dermatitis (SCORAD) |
baseline to 60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The Secondary outcome of the study is to evaluate the changes in Dermatology Life Quality Index(DLQI) |
baseline to 60 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/07/2023 |
| Date of Study Completion (India) |
29/04/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
The present work was taken to assess the action of herbal formulations in patients suffering from Contact Dermatitis. The study population was 60 patients randomly divided into two equal groups of 30 individuals. Group A – Subjects were advised to apply formulation( ECZ-cream-01) to cover lesions sufficiently ( cream formulations). Group B – Subjects were advised to apply cream-based coconut oil(ECZ- cream 02) to cover lesions sufficiently. The primary outcome of the study was to evaluate the changes in SCORing Atopic Dermatitis (SCORAD), the Secondary outcome of the study was to evaluate the changes in Dermatology Life Quality Index(DLQI) from baseline to 60 days. |