| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B359||Dermatophytosis, unspecified. Ayurveda Condition: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 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 | | 2 | Comparator Arm | Procedure | - | 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 | | 3 | Intervention Arm | Drug | Classical | | (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 "Tineaâ€, 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.
|