| CTRI Number |
CTRI/2025/01/079629 [Registered on: 28/01/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment of Tinea Corporis fungal infection disease symptoms such as itching, redness, pistules etc,using Ayurvedic formulations |
|
Scientific Title of Study
|
A single blind randomised controlled clinical study to evaluate the combined efficacy of Dvitiya edagajadi lepa and Aragvadhadi kashaya over Prathama edagajadi lepa and Aragvadhadi kashaya in Dadru kushta with special reference to Tinea Corporis |
| 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 Sangeetha G M |
| Designation |
PG Scholar |
| Affiliation |
Shri DGM ayurvedic medical college, kalsapur road, shivanand nagar Gadag. 582103 |
| Address |
Sangeetha G M Dept of Kayachikitsa opd number 03
Gadag
KARNATAKA
581203
India |
| Phone |
9632332155 |
| Fax |
|
| Email |
sangeetagm8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yasmeen A Phaniband |
| Designation |
Principal and professor |
| Affiliation |
Shri DGM Ayurvedic medical college, Kalsapur road, Shivanand nagar Gadag. 582103 |
| Address |
Dr Yasmeen A Phaniband Dept of Kayachikitsa opd number 03
Gadag
KARNATAKA
582103
India |
| Phone |
9845515865 |
| Fax |
|
| Email |
yasmeenphaniband@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sangeetha G M |
| Designation |
PG Scholar |
| Affiliation |
Shri DGM ayurvedic medical college, kalsapur road, shivanand nagar Gadag. 582103 |
| Address |
Sangeetha G M Dept of Kayachikitsa opd number 03
Gadag
KARNATAKA
581203
India |
| Phone |
9632332155 |
| Fax |
|
| Email |
sangeetagm8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri DGM Ayurvedic Medical College And Hospital Gadag 582103
|
|
|
Primary Sponsor
|
| Name |
Dr Sangeetha GM |
| Address |
DGM Ayurvedic medical college and hospital PG PhD centre Kalsapur road, Shivanand nagar Gadag.582103 KARNATAKA
|
| 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 Sangeetha GM |
Shri DGM Ayurvedic medical college and hospital Shivanand nagar, Kalaspur road Gadag. 582103 |
Kayachikitsa opd, room number 03
Gadag
KARNATAKA |
9632332155
sangeetagm8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DGM AYURVEDIC MEDICAL COLLEGE ETHICAL CLEARNCE COMMITTE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: DADRU, (2) 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 | Procedure | - | lepa, लेप | (Procedure Reference: Sharangdhara samhita, Procedure details: Purva karma
Prepared fine choorna is taken in a vessel then any amla dravya (i.e Sour gruel or powder kept in curd water for 3 days) should be added in sufficient quantity soft paste of medium consistency is prepared.
Pradana karma
Subject is made to sit in comfortable position affected skin lesion is exposed then paste is applied gently around the lesion ( circumference of about 2-3 cm) in thick form about 4-5 mm
Paschat karma
Removed the applied paste once it gets dried and wipe it with cloth dipped in Luke warm water with all precautions.
)
(1) Medicine Name: Dwitiya edagajadi lepa, Reference: Chakradutta samhita, Route: Topical, Dosage Form: Churna/ Powder, Dose: 0(NA), Frequency: bd, Duration: 45 Days | | 2 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: Sharangadhara samhita, Procedure details: Purva karma
Prepared fine choorna is taken in a vessel then any amla dravya (i.e Sour gruel or powder kept in curd water for 3 days) should be added in sufficient quantity soft paste of medium consistency is prepared.
Pradana karma
Subject is made to sit in comfortable position affected skin lesion is exposed then paste is applied gently around the lesion ( circumference of about 2-3 cm) in thick form about 4-5 mm
Paschat karma
Removed the applied paste once it gets dried and wipe it with cloth dipped in Luke warm water with all precautions.
)
(1) Medicine Name: Prathama edagajadi lepa, Reference: Chakradutta samhita, Route: Topical, Dosage Form: Churna/ Powder, Dose: 0(NA), Frequency: bd, Duration: 45 Days | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Aragvadhadi kashaya, Reference: Chakradutta samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Sukoshna jala), Additional Information: - |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects having the signs and symptoms like Viz Kandu, Raaga,Pidaka and Udgatam mandala.
2.Age group between 18- 65 of either sex
3.Subjects willing participate and complete with all study prescribed for prescribed trial period
4.Subjects willing to give a written consent
5.Subjects not using any topical and oral treatment for Dadru Kushta for 2 weeks prior to enrollment to study |
|
| ExclusionCriteria |
| Details |
1.Any medical condition, laboratory finding or physical examination findings like vital signs outside of specific range
2.If patient is on any concomitant medication like oral contraceptive, Thyroid medication etc
3.Patients with history of systemic illness like Diabetic mellitus, Hypertension, Endocrine disorder,Cardiac pathology, Cancer, Immune system disorder like AIDS.
4.Any known allergic reaction to component of study products
5.History of drug or alcohol abuse.
6.Pregnant and lactating women
7.Patient who have taken topical or oral steroids within one month prior to enrollment
8.Patient under treatment of another Dermatological condition |
|
|
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
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Changes in signs and symptoms of Dadru kushta such as reduction in size and color of lesion and other symptoms like kandu, pidaka and udgatam mandala etc
2.Improvement in the scale |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Absence of scars from healed lesion
2.No occurrence of the same |
60 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
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/02/2025 |
| 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="0"
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
|
A healthy skin reflects the health of an individual. Skin is considered as one of the most important part of the body. It acts as primary defence system and also known as largest organ of the human body it is the first organ of the body interacting with environmental stimuli and natural ability of body. Dadru kusta is Raktavaha sroto vyadhi having symptoms of iching skin, rashes etc.In Contemporary medicine Dadru kushta is correlated to fungal infection that is Tinea. In modern medical science management of Tinea infection is carried out with usage of topical therapy alone, systemic therapy indicated for patients of Tinea are unresponsive In modern the long term usage of antifungal drugs like Azole group of drugs such as ketoconazole or Itraconazole is known to cause anaphylaxis by excreting toxins and drugs into the intestine .So prolonged intake of these antifungal drugs will leads to side effects like liver damage and altered estrogen level .Many antifungal medicines can cause severe allergic reactions such as blisters and peeling of skin or may leads to skin related diseases .Resistance can also develop over the time when fungi are exposed to antifungal drugs .The Ayurvedic formulation of bahirparimargana in the form of lepa and shamana aushadi should be taken which can acts as sthanika chikitsa externally and internally, do rakta shuddi so that disease will be cured from root.The Ayurvedic formulations having the property to completely cure this dadru kushta and the chances of reoccurrence are also very less.There are numerous yogas in the form of lepa in Ayurveda for the treatment of Dadru Kushta. · The drugs selected under this study were Dvitiya edagajadi lepa for external application and Aragvadhadi kashaya nternally from Chakradatta and prathama Edagajadi lepa for external application and Aragvadhadi kashaya for internally from Chakradatta The drug Aragvadadha having the property of kushtaghna ,kapha pitta shamana and helps in subsiding the Dadru kushta as a shamana aushadi .
· The whole drugs of Dvitiya Edagajadi lepa having katu tiktha kashaya rasas,laghu, ruksha, tikshna gunas and having the properties of tridoshagna, kushtaghna, kandughna, krimighna, tvachya, rasayana also having shodana properties and easily available and method of preparation and administration is also easy to approach for the patient.Thus by keeping above aims this clinical trial has been selected
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