To Study the efficacy of Kushthaghna Mahakashaya and Jalaukaavcharan in the management of Dadru Kushtha

Not yet recruiting

• Conditions: Dermatitis and eczema. Ayurveda Condition: DADRU-KUSHTHAH,

• Registration Number: CTRI/2022/03/040808
• Lead Sponsor: Shri Krishna AYUSH University Kurukshetra Haryana

Brief Summary

BRIEFSUMMARY ON PURPOSE –

  Dermatophytosis, also known asringworm, is a fungal infection of the skin. Dermatopytosis or tinea ispredominance in about 20%-25% to all total world populations. In India, theprevalence of superficial fungal infection was 27.6%, Dermatophytosis was 75.6%and non- dermaophytosis was 24.4%. In Ayurveda, Dadrukushtha is correlated toDermatophytosis. While thinking of the treatment, satisfactory treatment isstill not available for Dermatophytosis. Modern medical science prescribeddifferent types of treatment modalities for dermatophytosis like topical andsystemic antifungal agents and use of corticosteroids which is very expensiveand having side effects and also its recurrence rate is high. So, the thoughtof exploring a drug which is cost effective and having properties to reducesign and symptoms of Dadru Kushtha along with least recurrence rate, triggeredthis clinical research. In Charak Samhita, the Kushthaghna Mahakashaya has beenprescribed for the management of Kushtha and Dadrukushtha is one among thetypes of Kushtha.

 As per Ayurveda, externalapplication like lepa has major role in treatment of Dadru Kushtha but it hasits own limitations like shorter shelf life, difficulty in handling, problem ofmaking 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 presentstudy, an attempt was made to prepare Kushthaghna Mahakashaya Ointment fortopical application.

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

   RESEARCH QUESTION:

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

  BACKGROUND OF TRIAL: It is aninterventional study.

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

  This is a Randomised clinical opentrial, in which a minimum of 90 patients of either sex, suffering from DadruKushtha will be selected. The study will be conducted at Shri Krishna AYUSHUniversity, 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 Mahakashayaointment sufficient for local application on affected parts of the body twice aday (morning and evening) as per the size of dadru kushtha. Group B - Patientswill be treated with Jalaukaavcharan one sitting per week. Group C - Patientswill be treated with Kushthaghna Mahakashaya ointment and Jalaukaavcharan both.

  Period of Trial: 28 days (4 weeks).

   Subjective Criteria:

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

·        Kandu

·        Raga

·        Ruja

·        Visarpana

  Objective Criteria:

ï‚· Number ofMandal

ï‚· Size ofMandal

ï‚· Number of Pidka

 Laboratory Investigations

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

ï‚· Urineexamination - Macroscopic and Microscopic

ï‚· HIV Test, HBsAg

   Finding – There will be asignificant effect of Kushthaghna Mahakashaya ointment and Jalaukaavcharan inthe management of Dadru Kushtha w.s.r.to Dermatophytosis.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-02-21
• Study Start: 2022-03-29

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Murari Lal Rasiwasia Ayurvedic College Hospital Charkhi Dadri Haryana; 🇮🇳 Bhiwani, HARYANA, India

Murari Lal Rasiwasia Ayurvedic College Hospital Charkhi Dadri Haryana

🇮🇳Bhiwani, HARYANA, India

Ritu Kumari

Principal investigator

8826913595

ritusolnki2390@gmail.com