| 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 |
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|
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 |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
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:L20-L30||Dermatitis and eczema. Ayurveda Condition: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (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: | | 2 | Intervention Arm | Procedure | - | 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 | | 3 | Intervention Arm | Procedure | - | 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.)
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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 |
|
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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 |
|
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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
|
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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.
|