| CTRI Number |
CTRI/2024/09/074245 [Registered on: 24/09/2024] Trial Registered Prospectively |
| Last Modified On: |
24/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to find the effect of the Siddharthakadi Agad in fungal infection |
|
Scientific Title of Study
|
Clinical evaluation of the Siddharthakadi Agad in Dadru |
| 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 Ramesh Chandra Tiwari |
| Designation |
Professor and H.O.D. P.G. Department of Agad Tantra |
| Affiliation |
Rishikul Ayurvedic College UAU Haridwar |
| Address |
Residential colony near OPD Rishikul Ayurvedic college Haridwar
P.G Department of Agadtantra,Rishikul Campus Haridwar, Uttrakhand Ayurved University,Haridwar, Uttarakhand 249401
Hardwar
UTTARANCHAL
249401
India |
| Phone |
6396527025 |
| Fax |
|
| Email |
agadtantra786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Chandra Tiwari |
| Designation |
Professor and H.O.D. P.G. Department of Agad Tantra |
| Affiliation |
Rishikul Ayurvedic College UAU Haridwar |
| Address |
Residential colony near OPD Rishikul Ayurvedic college Haridwar
P.G Department of Agadtantra,Rishikul Campus Haridwar, Uttrakhand Ayurved University,Haridwar, Uttarakhand 249401
Hardwar
UTTARANCHAL
249401
India |
| Phone |
6396527025 |
| Fax |
|
| Email |
agadtantra786@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Muskan Rangar |
| Designation |
MD Scholar |
| Affiliation |
Rishikul Ayurvedic College UAU Haridwar |
| Address |
Rishikul Ayurvedic College UAU Haridwar
department of Agadtantra and Vidhivaidhyak
Uttarkashi
UTTARANCHAL
249401
India |
| Phone |
09119009477 |
| Fax |
|
| Email |
muskanrangar01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rishikul Campus, Uttrakhand Ayurved University, Haridwar 249401 India |
|
|
Primary Sponsor
|
| Name |
Uttrakhand Ayurved University |
| Address |
Uttrakhand Ayurved University, Railway Road, Harrawala Dehradun 248001 India |
| Type of Sponsor |
Government 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 |
| DrMuskan Rangar |
Rishikul Ayurvedic Hospital |
OPD NO.2 Agadtantra and Vidhivadiyak Department, Rishikul, Haridwar, Uttarakhand Ayurved University Haridwar Uttarakhand 349401 India Haridwar UTTARANCHAL
Hardwar
UTTARANCHAL |
09119009477
muskanrangar01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Uttarakhand Ayurved University, Rishikul Campus Haridwar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Siddharthakadi Agad, Reference: Charak Samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Siddharthakadi Agad, Reference: Charak Samhita, Route: Topical, Dosage Form: Lepa Churna, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Normal water), Additional Information: -Churna lepa will be applied over effected area, twice a day. |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient having classical feature of Dadru(Kandu, Raga, Pidika, Utsanna Mandala)
2.Patients between age group between 20-60 years will be selected for the study
3.Patient of both genders
4.Chronicity up to 5 years |
|
| ExclusionCriteria |
| Details |
1.Kushtha other than Dadru
2.Pregnant and lactating women
3.Patient suffering from known case of diabetes mellitus
4.Patient with systemic illness which might interfere in the present study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Decrease in itching.
2.Decrease in eruptions.
3.Decrease in redness. |
Follow up at an interval of 15 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Reduced area occupied by the mandala.
2.Reduced subjective parameters.
3.Reduced objective parameters. |
Follow up at an interval of 15 days. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
05/10/2024 |
| 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 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
|
In contemporary science Dadru has been compared to Dermatophytosis (a group of fungus that colonizes and multiplies in dead keratin). All symptoms of Dadru i.e. Kandu,Raga, Durvavata-Deergha pratan, Utsann Mandala, Pidika are quite similar to Dermatophytosis also known as ringworm. Usually, it causes a circular, red, scaly, itchy, rash which affects large no of population worldwide. Classical formula known as Siddharthakadi Agad is selected for this trial. The aim of the study is "clinical evaluation of Siddharthakadi Agad in Dadru". The duration of treatment will be of 60 days (45 days with medication and 15 days without medication). In this four assessments will be done at an interval of 15 days. Patient will be registered from OPD NO2 of PG department of Agad tantra and Vidhi Vaidhyak, Rishikul, Campus, Haridwar, Uttarakhand Ayurved University. |