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CTRI Number  CTRI/2024/09/074292 [Registered on: 24/09/2024] Trial Registered Prospectively
Last Modified On: 13/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A comparative study on efficacy of Aragvadha patra lepa vs Chakramarda beeja lepa in Dadru kushtha i.e. Dermatophytosis 
Scientific Title of Study   A comparative clinical and antimicrobial study on efficacy of Aragvadha patra lepa vs Chakramarda beeja lepa in Dadru kushtha(Dermatophytosis) 
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 Dipika Yadav 
Designation  MD Scholar, Department Of Roga Nidana Evum Vikriti Vigyana 
Affiliation  All India Institute Of Ayurveda 
Address  Department of Roga Nidana Evum Vikriti Vigyana, 3rd floor, Academic block, Block C, All India Institute of Ayurveda, Gautampuri, Sarita vihar, Mathura road, New Delhi

South
DELHI
110076
India 
Phone  7082863762  
Fax    
Email  dgunwal1234@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shalini Rai 
Designation  Associate Professor  
Affiliation  All India Institute Of Ayurveda 
Address  Department of Roga Nidana Evum Vikriti Vigyana, 3rd floor, Academic block, Block C, All India Institute of Ayurveda, Gautampuri, Sarita vihar, Mathura road, New Delhi

South
DELHI
110076
India 
Phone  9389423843  
Fax    
Email  vd.raishalini@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Dipika Yadav 
Designation  MD Scholar, Department Of Roga Nidana Evum Vikriti Vigyana 
Affiliation  All India Institute Of Ayurveda 
Address  Department of Roga Nidana Evum Vikriti Vigyana, 3rd floor, Academic block, Block C, All India Institute of Ayurveda, Gautampuri, Sarita vihar, Mathura road, New Delhi

South
DELHI
110076
India 
Phone  7082863762  
Fax    
Email  dgunwal1234@gmail.com  
 
Source of Monetary or Material Support  
All India Institute Of Ayurveda Gautampuri Sarita Vihar New Delhi 110076 
 
Primary Sponsor  
Name  All India Institute Of Ayurveda 
Address  All India Institute Of Ayurveda, Gautampuri, Sarita vihar, Mathura road, New Delhi 110076 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Dipika Yadav  All India Institute Of Ayurveda  Department of Roga Nidana Evum Vikriti Vigyana, OPD Ground floor, Hospital Block, All India Institute of Ayurveda, Gautampuri, Sarita vihar, Mathura road, New Delhi 110076
South
DELHI 
7082863762

dgunwal1234@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, All India Institute Of Ayurveda, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:B359||Dermatophytosis, unspecified. Ayurveda Condition: DADRU-KUSHTHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-lepa, लेप (Procedure Reference: Bhaisajya ratnavali, Procedure details: Contents: Preparation of lepa of Aragvadha patra with Kanji Consistency/Thickness: The paste will then be applied with a thickness of 4-5 mm Directions for application: against the direction of hair follicle Time: Two times in a day Duration: Till drying Procedure: 1. As per the affected area, Aragvadha Patra churna and Chakramarda beeja churna will be taken and soaked with the Kanji for about 60 minutes with the consistency to form a paste. 2.The affected area will be cleaned with cotton soaked in clean potable water. 3.The paste will then be applied with a thickness of 4-5 mm against the direction of hair follicle. 4. The lepa will be allowed to stay till drying, after which it will be removed by rubbing it off. 5. The part will then be allowed to stay dry for the rest part of the day. )
(1) Medicine Name: Aragvadha patra lepa, Reference: Bhaisajya ratnavali, Route: Topical, Dosage Form: Lepa Churna, Dose: 2(g), Frequency: bd, Duration: 45 Days
2Comparator ArmProcedure-lepa, लेप (Procedure Reference: Bhavprakash Nighantu, Procedure details: Contents: Preparation of lepa of Chakramarda beeja with Kanji Consistency/Thickness: The paste will then be applied with a thickness of 4-5 mm Directions for application: against the direction of hair follicle (17) Time: Two times in a day Duration: Till drying Procedure: 1. As per the affected area, Aragvadha Patra churna and Chakramarda beeja churna will be taken and soaked with the Kanji for about 60 minutes with the consistency to form a paste. 2.The affected area will be cleaned with cotton soaked in clean potable water. 3.The paste will then be applied with a thickness of 4-5 mm against the direction of hair follicle. 4. The lepa will be allowed to stay till drying, after which it will be removed by rubbing it off. 5. The part will then be allowed to stay dry for the rest part of the day. )
(1) Medicine Name: Chakramarda beeja lepa, Reference: Bhavprakash Nighantu, Route: Topical, Dosage Form: Lepa Churna, Dose: 2(g), Frequency: bd, Duration: 45 Days
3Intervention ArmDrugClassical(1) Medicine Name: Varadi yoga, Reference: Astang Hridya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient with classical sign and symptoms of Dadru Kushtha, irrespective of chronicity, recurrence or size of the lesion.
Patients willing to participate.
 
 
ExclusionCriteria 
Details  Pregnant and lactating women
Immunocompromised patients, HIV positive, Hepatitis- B positive, malignancy, tuberculosis.
Patients suffering from Diabetes and coronary artery disease.
Known history of hypersensitivity to the drugs incorporated in the study.
Chronic obstructive pulmonary disease, Chronic kidney or liver disease.
Any other criteria or major illnesses that investigator find inappropriate for the study were not taken.
Patient on any immunosuppressive therapy.
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
FOR INTERVENTIONAL STUDY
Percentage resolution of the clinical signs and symptoms of Dadru kushtha in both the groups after 45 days and observing the Anti-microbial effect of drugs using culture and sensitivity.

 
FOR INTERVENTIONAL STUDY
Percentage resolution of the clinical signs and symptoms of Dadru kushtha in both the groups after 45 days i.e. follow up for 2 months and observing the Anti-microbial effect of drugs using Culture & sensitivity i.e.at baseline

 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in DLQI after treatment in both the groups.
The recurrence rates in both treatment groups till 105th day of the study.
Incidence of adverse effects associated with each treatment modality.
 
Changes in DLQI after treatment in both the groups.i.e.0th,15th,30th & 45th day.
The recurrence rates in both treatment groups till 105th day of the study.
Incidence of adverse effects associated with each treatment modality.
 
 
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 2/ Phase 3 
Date of First Enrollment (India)   05/01/2025 
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 Yet Recruiting 
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 Ayurveda, several skin conditions are included under the Kushtha Roga category. Kushtha is regarded as one of the eight Mahagads as well. (1)

Kushtha Roga has eighteen types, divided into two categories: Maha Kushtha and Kshudra kushtha. According to ’Acharya Charaka’ and ’Acharya Sushruta,’ Dadru is categorized as a Kshudra Kushtha and a Maha Kushtha respectively. Presenting with the features of circular lesion associated with itching, reddish or brownish-blackish rash, dadru resembles the clinical picture of dermatophytosis.

               The dermatophytes are a collection of closely related fungi that can infect humans and other animals by invading keratinized tissue, such as skin, hair, and nails. Commonly known as ringworm infections, dermatophytosis falls under skin infections caused by superficial fungi. The incubation period of this fungi is 7 – 14 days. These fungi thrive in warm and moist environments, making areas such as the groin, feet, and scalp particularly susceptible.

Dermatophyte infections are named based on the anatomical site in which they occur, with the Latin title for that site coming after the word "Tinea”, like Tinea corporis (2).

NEED OF STUDY-

Skin diseases account for over 12.4 percent (8) of all diseases worldwide in which a significant portion of them are caused by fungi, with ringworm responsible for 10 to 15% of global infections at current moment (9). The advent of recurrence and anti–fungal resistance has also added to the impact of the problem. Due to increase in the cases of anti-fungal drug resistance there is a need to test new leads for the effective and safe treatment of dermatophytosis. This study will assess the anti-microbial effect of Aragvadha patra through sensitivity and clinical study in comparison to Chakramarda beeja lepa, both administered with Kanji and Varadi yoga (oral) over a 45-day treatment period in management of Dadru kushtha (Dermatophytosis). To the best of our knowledge no research has been carried out on the efficacy of Aragvadha patra or Varadi yoga in Dadru kushtha (dermatophytosis). This study will compare the efficacy of the drug Aragvadha patra to standard control drug Chakramarda beeja lepa which is well researched drug for its efficacy on Dadru kushtha (dermatophytosis).

AIM-

1.To estimate the clinical efficacy of 45 days of Aragvadha patra lepa application with kanji and Varadi yoga (oral) in comparison to Chakramarda beeja lepa with kanji along with Varadi yoga (oral) in the patients of Dadru kushtha (Dermatophytosis).

2. To assess the anti-microbial activity of Aragvadha Patra and Chakramarda Beeja through sensitivity study.

OBJECTIVES-

INTERVENTIONAL STUDY:

PRIMARY OBJECTIVE: 

1. To estimate the clinical efficacy of Aragvadha patra lepa in comparison to Chakramarda beeja lepa, both administered with kanji and Varadi yoga (oral) in the resolution of signs and symptoms of Dadru kushtha (Dermatophytosis).

SECONDARY OBJECTIVES:

1. To study the KOH mount and culture and sensitivity study of each of the enrolled cases affected area skin scrapings.

2. To assess the improvement in dermatology life quality index in both the groups at the end    of 45 days trial duration.

3. To assess the safety of the study drugs used at the end of 45 days.

4. To record the recurrence at the end of 60 days after the trial completion in both the groups.

IN-VITRO STUDY

PRIMARY OBJECTIVE: 

·       To observe the anti-microbial effect of Aragvadha patra and Chakramarda Beeja through sensitivity study.

 

OUTCOMES:

INTERVENTIONAL STUDY:

 Primary Outcome -

1. Percentage resolution of the clinical signs and symptoms of Dadru kushtha in both the groups after 45 days.

Secondary Outcomes:

1. Changes in DLQI after treatment in both the groups

2. The recurrence rates in both treatment groups till 105th day of the study.

3. Incidence of adverse effects associated with each treatment modality.

IN-VITRO STUDY

  Primary Outcome –

·    Anti-microbial effect of drugs using In-vitro study.

 

 
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