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CTRI Number  CTRI/2022/03/040808 [Registered on: 04/03/2022] Trial Registered Prospectively
Last Modified On: 21/02/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To Study the efficacy of Kushthaghna Mahakashaya and Jalaukaavcharan in the management of Dadru Kushtha 
Scientific Title of Study   Evaluation of Pre-clinical efficacy of Kushthaghna Mahakashaya and Clinical efficacy of Kushthaghna Mahakashaya Ointment and Jalaukaavcharan in the management of Dadru Kushtha w.s.r.to Dermatophytosis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ritu Kumari 
Designation  PhD Scholar 
Affiliation  Shri Krishna AYUSH University Kurukshetra Haryana  
Address  Room No 102 1st Floor Department of Shalya Tantra Shri Krishna AYUSH University Umri Road Kurukshetra
Shri Krishna AYUSH University Umri Road Sector 8 Kurukshetra Haryana 136118
Kurukshetra
HARYANA
136118
India 
Phone  8826913595  
Fax    
Email  ritusolnki2390@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajender Singh 
Designation  Associate Professor  
Affiliation  Shri Krishna AYUSH University Kurukshetra Haryana  
Address  Room No 102 1st Floor Department of Shalya Tantra, Shri Krishna AYUSH University, Umri Road, Kurukshetra
Shri Krishna AYUSH University, Umri Road, Sector 8, Kurukshetra, Haryana 136118
Kurukshetra
HARYANA
136118
India 
Phone  9416662761  
Fax    
Email  drrajendersingh1346@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rajender Singh 
Designation  Associate Professor  
Affiliation  Shri Krishna AYUSH University Kurukshetra Haryana  
Address  Room No 102 1st Floor Department of Shalya Tantra, Shri Krishna AYUSH University, Umri Road, Kurukshetra
Shri Krishna AYUSH University, Umri Road, Sector 8, Kurukshetra, Haryana 136118
Kurukshetra
HARYANA
136118
India 
Phone  9416662761  
Fax    
Email  drrajendersingh1346@gmail.com  
 
Source of Monetary or Material Support  
Shri Krishna AYUSH University Kurukshetra Haryana  
 
Primary Sponsor  
Name  Shri Krishna AYUSH University Kurukshetra Haryana  
Address  Department of Shalya Tantra Room No 102 Shri Krishna AYUSH University Kurukshetra Haryana India 
Type of Sponsor  Government medical college 
 
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 
Ritu Kumari  Murari Lal Rasiwasia Ayurvedic College Hospital Charkhi Dadri Haryana   First Floor Department of Shalya Tantra Murari Lal Rasiwasia Ayurvedic College Hospital Charkhi Dadri Haryana
Bhiwani
HARYANA 
8826913595

ritusolnki2390@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L20-L30||Dermatitis and eczema. Ayurveda Condition: DADRU-KUSHTHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Kushthaghna Mahakashaya , Reference: Charak Sutra 4/13, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information:
2Intervention ArmProcedure-Jalaukaavcharan (Procedure Reference: Sushruta Chikitsa 9/6 and Ashtang Hrudya sutra 26/42, Procedure details: The procedure will be carried out as purvakarma, pradhan karma and pashchat karma according to standard protocol.The duration of procedure will be once in a week for 4 weeks.)
(1) Medicine Name: Kushthaghna Mahakashaya, Reference: Charak Sutra 4/13, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(g), Frequency: bd, Duration: 4 Weeks
3Intervention ArmProcedure-Jalaukaavcharan (Procedure Reference: Sushruta Chikitsa 9/6 and Ashtang Hrudya sutra 26/42, Procedure details: The procedure will be carried out as purvakarma, pradhan karma and pashchat karma according to standard protocol.The duration of procedure will be once in a week for 4 weeks.)
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Patient with classical signs and symptoms of Dadru Kushtha - Kandu, Raga, Mandal and Pidka.
2 Patients of either sex
3 Patients having age group of 20-60 years.
4 Willingness of patients for study 
 
ExclusionCriteria 
Details  1 Age below 20 years & above 60 years.
2 Patient with uncontrolled Hypertension/ Diabetes Mellitus / Tuberculosis / Hepatitis and any systematic disorder.
3 Carcinoma
4 Bleeding disorders
5 Pregnancy
6 HIV
7 VDRL
8 HBsAg 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To rule out the result of Kushthaghna Mahakashaya Ointment and Jalaukaavcharan in the management of Dadru Kushtha considering subjective parameters Kandu,Raga,Ruja and objective parameters Number of mandal,size of mandal and number of pidika.  at baseline,1 week, 2 week, 3 week,4 week.  
 
Secondary Outcome  
Outcome  TimePoints 
To rule out significant result of Kushthaghna Mahakashaya Ointment in the management of Dadru Kushtha considering subjective parameters Kandu,Raga,Ruja and objective parameters Number of mandal,size of mandal and number of pidika.   at baseline, 1 week, 2 week, 3 week and 4 week 
To rule out significant result of Jalaukaavcharan in the management of Dadru Kushtha considering subjective parameters Kandu,Raga,Ruja and objective parameters Number of mandal,size of mandal and number of pidika.  at baseline, 1 week, 2 week, 3 week, 4 week 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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   N/A 
Date of First Enrollment (India)   29/03/2022 
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   NOT YET 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

BRIEF SUMMARY ON PURPOSE –

 

 

Dermatophytosis, also known as ringworm, is a fungal infection of the skin. Dermatopytosis or tinea is predominance in about 20%-25% to all total world populations. In India, the prevalence of superficial fungal infection was 27.6%, Dermatophytosis was 75.6% and non- dermaophytosis was 24.4%. In Ayurveda, Dadrukushtha is correlated to Dermatophytosis. While thinking of the treatment, satisfactory treatment is still not available for Dermatophytosis. Modern medical science prescribed different types of treatment modalities for dermatophytosis like topical and systemic antifungal agents and use of corticosteroids which is very expensive and having side effects and also its recurrence rate is high. So, the thought of exploring a drug which is cost effective and having properties to reduce sign and symptoms of Dadru Kushtha along with least recurrence rate, triggered this clinical research. In Charak Samhita, the Kushthaghna Mahakashaya has been prescribed for the management of Kushtha and Dadrukushtha is one among the types of Kushtha.

 

As per Ayurveda, external application like lepa has major role in treatment of Dadru Kushtha but it has its own limitations like shorter shelf life, difficulty in handling, problem of making everyday etc. Thus, there is a need to think about its modification. So, modification of the lepa into ointment form will be performed. In the present study, an attempt was made to prepare Kushthaghna Mahakashaya Ointment for topical application.

Dadru Kushtha shows vitiation of tridoshas but according to law of predominance it shows Pitta & Kapha as major vitiation and the Rakta and Twak are considerably included in pathology as dushya. So, Jalaukaavcharan will be performed also for treatment of Dadru Kushtha.

 

 

 

 RESEARCH QUESTION:

 

Is the Kushthaghna Mahakashaya Ointment & Jalaukaavcharan effective in treatment of Dadru Kushtha?

 

 

BACKGROUND OF TRIAL: It is an interventional study.

 

 

Firstly, the Pre-clinical study will be performed to evaluate the in-vitro anti-fungal efficacy of Kushthaghna Mahakashaya and its constutuent herbs. For this ethanolic and aqueous extract of Kushthaghna Mahakashaya drugs will be taken against the fungal strains of Microsporum, Epidermophyton & Trichophyton responsible for the disease. Extraction, ointment preparation, phytochemical evaluation will be done at Research & Innovation Department, Shri Krishna AYUSH University, Kurukshetra

 

 

This is a Randomised clinical open trial, in which a minimum of 90 patients of either sex, suffering from Dadru Kushtha will be selected. The study will be conducted at Shri Krishna AYUSH University, Kurukshetra and Murari Lal Rasiwasiya Ayurvedic College Hospital, Charkhi Dadri, Haryana. Groups: 3 groups (30 patients in each group) Group A- Patients will be treated with Topical application of Kushthaghna Mahakashaya ointment sufficient for local application on affected parts of the body twice a day (morning and evening) as per the size of dadru kushtha. Group B - Patients will be treated with Jalaukaavcharan one sitting per week. Group C - Patients will be treated with Kushthaghna Mahakashaya ointment and Jalaukaavcharan both.

 

 

Period of Trial: 28 days (4 weeks).

 

 

 

Subjective Criteria:

 

Subjective parameters will be assessed before and after the treatment as per the grade score.

·         Kandu

·         Raga

·         Ruja

·         Visarpana

 

 

Objective Criteria:

ï‚· Number of Mandal

ï‚· Size of Mandal

ï‚· Number of Pidka

 

Laboratory Investigations

 

ï‚· Routine haematological investigations RBS, TLC, DLC, CT, BT, Hb%, ESR

ï‚· Urine examination - Macroscopic and Microscopic

ï‚· HIV Test, HBsAg

 

 

 

Finding – There will be a significant effect of Kushthaghna Mahakashaya ointment and Jalaukaavcharan in the management of Dadru Kushtha w.s.r.to Dermatophytosis.

 

 

 

 

 

 
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