CTRI Number |
CTRI/2023/05/052676 [Registered on: 16/05/2023] Trial Registered Prospectively |
Last Modified On: |
11/12/2024 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
A Study to evaulate the efficacy of Dadrughna Lepa in Fungal Dermatophytosis. |
Scientific Title of Study
|
A Randomized open labelled controlled clinical study to evaulate the efficacy of Dadrughna Lepa in the management of Dadu Kushta with special reference to Fungal Dermatophytosis. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr VISHNU S |
Designation |
PG SCHOLAR |
Affiliation |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL, BENGALURU |
Address |
ROOM NO 304,DEPARTMENT OF PG STUDIES IN
KAYACHIKITSA,
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH, BENGALURU
Bangalore KARNATAKA 560076 India |
Phone |
9535417658 |
Fax |
|
Email |
vishnu07997@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr SOWMYASHREE U P |
Designation |
ASSOCIATE PROFESSOR |
Affiliation |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL, BENGALURU |
Address |
ROOM NO 304,DEPARTMENT OF PG STUDIES IN
KAYACHIKITSA,
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH, BENGALURU
Bangalore KARNATAKA 560082 India |
Phone |
9743893056 |
Fax |
|
Email |
upsprasad@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr VISHNU S |
Designation |
PG SCHOLAR |
Affiliation |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL, BENGALURU |
Address |
ROOM NO 304,DEPARTMENT OF PG STUDIES IN
KAYACHIKITSA,
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH, BENGALURU
Bangalore KARNATAKA 560076 India |
Phone |
9535417658 |
Fax |
|
Email |
vishnu07997@gmail.com |
|
Source of Monetary or Material Support
|
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH |
|
Primary Sponsor
|
Name |
Dr VISHNU S |
Address |
ROOM NO 304,DEPARTMENT OF PG STUDIES IN
KAYACHIKITSA,
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH, BENGALURU |
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 VISHNU S |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL |
ROOM NO 05 DEPARTMENT OF KAYACHIKITSA SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH HOSPITAL BANGALORE Bangalore KARNATAKA |
9535417658
vishnu07997@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
SRI SRI INSTITUTIONAL ETHICAL 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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: DURVADI PRALEPA, Reference: VRUDDHA VAGBHATA CHIKITSA STHANA KUSHTA ROGA ADHIKARA, Route: Topical, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: TAKRA), Additional Information: INGREDIENTS ARE DURVA,HARITAKI,SAINDAVALAVANA,CHAKRAMARDA,THULASI.LOCALÂ APPLICATIONÂ WITHÂ TAKRAÂ INÂ REQUIREDÂ QUANTITY
(TAKRA TO BE KEPT OVERNIGHT SHOULD BE USED).ONCE DAILY MORNING, TO BE REMOVED BEFORE GETTING DRIED AND WASHED WITH LUKEWARM WATER | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: DADRUGHNA LEPA, Reference: BHAVAPRAKASHA MADHYAMA KHANDA KUSHTA ROGA ADHIKARA, Route: Topical, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: TAKRA), Additional Information: INGREDIENTS ARE KUSTHA,VAYA VIDANGA,CHAKRAMARDA,HARIDRA,SAINDAVA LAVANA AND RAJIKA. LOCAL APPLICATION WITH TAKRA IN REQUIRED QUANTITY
(TAKRA TO BE KEPT OVERNIGHT SHOULD BE USED).ONCE DAILY MORNING, TO BE REMOVED BEFORE GETTING DRIED AND WASHED WITH LUKEWARM WATER |
|
|
Inclusion Criteria
|
Age From |
21.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
SUBJECTS FALLING UNDER B36 OF ICD10 CLASSIFICATION,CLINICAL SIGNS AND SYMPTOMS OF DADRU KUSHTA AS DESCRIBED IN CLASSICAL TEXTS (PRESENCE OF UDGATA MANDALA WITH OR WITHOUT OTHER SYMPTOMS),SUBJECTS WILLING TO PARTICIPATE IN THE STUDY WITH WRITTEN INFORMED CONSENT WHICH IS CONVEYED IN THE LANGUAGE WHICH THE SUBJECT CAN UNDERSTAND |
|
ExclusionCriteria |
Details |
PREGNANT AND LACTATING WOMEN.
SUBJECTS HAVING ANY UNCONTROLLED SYSTEMIC ILLNESS WHICH CAN INTERFERE WITH THE COURSE OF DISESASE AND TREATMENT,
OTHER OVERLAPPING DERMATOLOGICAL DISEASES WILL BE EXCLUDED,
SUBJECTS UNDER ANTI-FUNGAL DRUGS WILL BE EXCLUDED. |
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Changes in KASI score |
before intervention-0th day
during intervention-10th day
after intervention-21st day
follow up-28th day |
|
Secondary Outcome
|
Outcome |
TimePoints |
NIL |
NIL |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
01/06/2023 |
Date of Study Completion (India) |
03/06/2024 |
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)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
NIL |
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 organ of the human body. Its size and external location make it susceptible to a wide variety of disorders.In recent years, there has been a considerable increase in the incidence of skin conditions in the tropical and developing countries like india.Skin disorders are known to be the fourth most common causes of all human diseases affecting nearly 1/3rd of population in the world.All the skin diseases are explained under the heading of Kushta in Ayurveda. Dadru Kushta is one of the commonly occurring skin disease and is KaphaPitta predominant.ED-4.3.6 specific code that can be used to indicate the Dadru Kushta as mentioned in NAMASTE PORTAL (National Ayush Morbidity and standardised terminologies electrical portal).The symptoms like Durvavat deerghapradhana indicates its spreading nature, Athasi indicates its coppery red colour, Kandu(itching) and Anushangini its chronic nature.Most of the features of Dadru Kushta is similar to the features of dermatophytosis.Dermatophytosis is the fungal infection of the skin.It can be developed from 40 types of fungi, of which dermatophytes trichophyton,microsporum and epidermophyton are the common causative agents.B5.9 is a specific ICD-10-CM code to indicate the diagnosis of Dermatophytosis.The typical clinical presentation of this disease is red, itchy and scaly circular lesion.Globally,up to 20% of the human population may be infected by dermatophyte at a time. The last few years shows a significant rise in the incidence of chronic Dermatophyte infections of skin,which have been proven difficult to treat.In contemporrary medical science, management of Dermatophytosis is carried out with Topical fungicidal agents like natamycin, clotrimazole, econazoles, miconazoles etc and systemic anti-fungal agents like Griseofulvin, Ketocenazole are advocated. Systemic fungicidal are highly toxic.Topical fungicidal require prolonged application and recurrence poses a problem in addition to appearance of resistance and long lasting usage produce the adverse effect like flaking of skin, irritation, redness etc.Hence,there is a need to contribute with safe and cost effective remedy in management of Dadru Kushta to effectively manage the disesase and not to cause any ill effects on body.In Ayurveda,many effective formulations without side effects are available. A series of studies conducted in recent past comprising of topical applications have showed mild to moderate response in Dadru Kushta. Here arises the importance of unique formulation in the management of Dadru Kushta. |