| CTRI Number |
CTRI/2024/08/072374 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
02/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of Chakramarda ointment when compared with Itraconazole ointment in fungal infection with 5D pruritus scale and KOH biomarker parameteres |
|
Scientific Title of Study
|
An Open Label Randomised Comparative Clinical Study to Evaluate The efficacy of Chakramarda Ointment And Itraconazole in the management of Dadru(TINEA) |
| 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 Vatsal N Parmar |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
OPD No 116 Department of Kayacikitsa Parul Ayurved Hospital Parul University AP Limda Tal Waghodia Vadodara Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9427555751 |
| Fax |
|
| Email |
vnparmar1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manu R |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
OPD No 116 Department of Kayacikitsa Parul Ayurved Hospital Parul University AP Limda Tal Waghodia Vadodara Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
8160858967 |
| Fax |
|
| Email |
manu.r260022@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arti Bhabhor |
| Designation |
Assistant professor |
| Affiliation |
Parul Institute of Medical Science |
| Address |
OPD No 16.4 Department of Skin & VD Parul Sevashram Hospital Parul University AP Limbda Tal Waghodia Vadodara Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9824817371 |
| Fax |
|
| Email |
arti.bhabhor12053@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Parul Institute of Ayurveda,Parul University,AP-Limbda,TAL-Waghodia,Vadodara,Gujarat,India-391760 |
|
|
Primary Sponsor
|
| Name |
Parul Institute of Ayurveda |
| Address |
Faculty of Ayurved Parul University AP Limbda Tal Waghodia Vadodara Gujarat India 391760 |
| Type of Sponsor |
Private 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 |
| Dr Vatsal N Parmar |
Parul Ayurved Hospital |
OPD No 116 Department of Kayachikitsa Parul Ayurved Hospital Parul University AP Limbda Tal Waghodia Vadodara Gujarat
Vadodara
GUJARAT |
9427555751
vnparmar1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul Institute of Ayurveda - Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B354||Tinea corporis. Ayurveda Condition: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: chakramarda ointment, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 10(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: TOPICAL APPLICATION ON INFECTED SKIN | | 2 | Comparator Arm (Non Ayurveda) | | - | Itraconazole ointment | local application for 1 month |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients having clinical symptoms like kandu,raga,mandala,pidika.
tinea corporis,cruris,capitis,pedis,mannum, |
|
| ExclusionCriteria |
| Details |
tinea ungium,tinea barbae.
k/c/o uncontrolled hypertension,diabetes mallitus.
pregnant and lactating woman |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of Chakramarda ointment when compared with Itraconazole ointment in fungal infection with 5D pruritus scale and KOH biomarker |
On screening visit,15th day & 30th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the effect of chakramarda ointment in comparison with itraconazole in management of dadru based on clinical symptoms/5d pruritus scale/biomarker KOH. |
On screening visit & 30th day |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/08/2024 |
| 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
|
Skin is the largest superficial covering of the body. In Ayurveda, all skin diseases are included in kushtha roga. Kustha is one of the Ashtamahagada mentioned by Acharyas. Kustha is further categorized as a Maha and Kshudra Kushta. Kushta is produced invariably by the vitiation of the 7 factors i.e. 3 doshas and 4 dushya. In Ayurved skin fungal infection is termed as Dadru. It is one of the most common Twak vikara affecting all the age groups of the population. There is no separate mention of nidana, poorvarupa mentioned for kustha can be considered here. Dadru gradually increases day to day because of improper vihara like uncleanliness of body, sankramika vyadhi. Dadru is kapha-pitta pradhan vyadhi. Acharya Charak mentioned dadru as a kshudra kustha its definition reddish color elevated border pidika in the form of a mandala and itching is known as dadru kustha.Acharya Sushruta and Vagbhata mentioned dadru as a Mahakustha. Dadru is managed by shodhana and Shamana Chikitsa. Tinea is the name of a group of diseases caused by fungus and it is also known as a ringworm or dermatophyte.Tinea is classified under superficial and deep mycosis. Tinea is a lesion with a central clearing surrounded by an advancing red, scaly, elevated border. One or more lesions may appear. Tinea is a lesion with a central clearing surrounded by an advancing red, scaly, elevated border. One or more lesions may appear. Dermatophyte infections are common worldwide, and dermatophytes are the prevailing causes of fungal infection of the skin, hair, and nails. |