| CTRI Number |
CTRI/2024/12/078387 [Registered on: 20/12/2024] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Trial To Study The Effect Of Aragwadhadhi Kwath In The Treatment Of Eczema. |
|
Scientific Title of Study
|
A Clinical Study To Evaluate The Efficacy Of Aragwadhadi Kwath In The Management Of Vicharchika With Special Reference To Eczema. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Naman Sain |
| Designation |
PG Scholar |
| Affiliation |
Kunwar Shekhar Vijendra Ayurved Medical College And Research Centre, Shobhit University. |
| Address |
Department Of Kayachikitsa Of Kunwar Shekhar Vijendra Ayurved Medical College And Research Centre Shobhit University Gangoh sahranpur(UP).
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
7988535522 |
| Fax |
|
| Email |
namansain773@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Naman Sain |
| Designation |
PG Scholar |
| Affiliation |
Kunwar Shekhar Vijendra Ayurved Medical College And Research Centre, Shobhit University. |
| Address |
Department Of Kayachikitsa Of Kunwar Shekhar Vijendra Ayurved Medical College And Research Centre Shobhit University Gangoh sahranpur(UP).
UTTAR PRADESH
247341
India |
| Phone |
7988535522 |
| Fax |
|
| Email |
namansain773@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bandana Dhall |
| Designation |
Professor |
| Affiliation |
Kunwar Shekhar Vijendra Ayurved Medical College And Research Centre, Shobhit University. |
| Address |
Department Of Kayachikitsa Of Kunwar Shekhar Vijendra Ayurved Medical College And Research Centre Shobhit University Gangoh sahranpur(UP).
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
9348061460 |
| Fax |
|
| Email |
bandanadhall1981@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kunwar Shekhar Vijendra Ayurved Medical College And Research Centre, Shobhit University, Gangoh. |
|
|
Primary Sponsor
|
| Name |
Kunwar Shekhar Vijendra Ayurved Medical College And Research Centre Shobhit University |
| Address |
Adarsh Institutional Area, Babu Vijendra Marg, Gangoh , Saharanpur. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Naman Sain |
Kunwar Shekhar Vijendra Ayurved Medical College And Research Centre, Shobhit University. |
Department Of Kayachikitsa Of Kunwar Shekhar Vijendra Ayurved Medical College And Research Centre Shobhit University Gangoh sahranpur(UP).
Saharanpur
UTTAR PRADESH |
07988535522
namansain773@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kunwar Shekhar Vijendra Ayurved Medical College And Research Centre, Shobhit University. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L309||Dermatitis, unspecified. Ayurveda Condition: KSHUDRAKUSHTHAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Aragwadhadi Kwath, Reference: Bhaisjya Ratnawali Chapter No. 54 Shloka No. 62-63, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Ghruta), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Subjects willing to sign the consent form.
2 Subjects having clinical features of Kandu, Pidaka, Shyava and Bahusrava of Vicharchika will be included in the study.
3 Subjects of both sexes in between 18 and 65 years of age
4 Eczema infections as per modern science Atopic dermatitis, Contact dermatitis, Statis dermatitis ,Seborrheic eczema will be included in this study.
|
|
| ExclusionCriteria |
| Details |
1 Subjects not willing for clinical trial.
2 Subject on steroids therapy and oral contraceptive therapy.
3 Subjects less than 18 years and more than 65 years.
4 Subjects with systemic disorders such as hypertension, diabetes mellitus, any carcinogenic disorder and HIV-positive patients.
5 Subjects having signs and symptoms of other skin disorders such as TB skin, scabies.
6 Undergone recent surgeries and taking immunosuppressive medicines.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of sign and symptoms of eczema(Vicharchika). |
45 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Cost effective treatment.
To observe if there is any adverse effect. |
45 Days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
06/01/2025 |
| 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 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
Modification(s)
|
The vounteer will be informed about the study protocol. Willing participants will be randomly selected as per computer generated table. The clinical research format will be validated. Single arm study. To assure the safety and efficacy of aragwadhadi kwath in the management of vicharchika(Eczema). Drug are given to subjects in a group of 60 patients.
|