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CTRI Number  CTRI/2023/07/054863 [Registered on: 06/07/2023] Trial Registered Prospectively
Last Modified On: 01/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Efficacy of Navaka Kashaya and Manjisthadi Tail in the management of dry eczema. 
Scientific Title of Study   A randomised controlled clinical trial on efficacy of Navaka Kashaya and Manjisthadi Tail in the management of Vicharchika with special reference to dry eczema 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Puja Agarwal 
Designation  MD Scholar Department Of Kayachikitsa. 
Affiliation  National Institute Of Ayurveda(De-Novo)  
Address  Department of Kayachikitsa National Institute of Ayurveda Deemed to be university Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  9587848547  
Fax    
Email  agarwalpuja2394@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof H M L Meena  
Designation  Professor 
Affiliation  National Institute of Ayurveda Deemed to be University  
Address  Department of Kayachikitsa National Institute of Ayurveda Deemed to be University Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  9461297017  
Fax    
Email  hari_mohan68@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Puja Agarwal 
Designation  MD Scholar Department Of Kayachikitsa 
Affiliation  National Institute Of Ayurveda(DE NOVO)  
Address  Department of Kayachikitsa National Institute of Ayurveda Deemed to be University Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  9587848547  
Fax    
Email  agarwalpuja2394@gmail.com  
 
Source of Monetary or Material Support  
NATIONAL INSTITUTE OF AYURVEDA DEEMED TO BE UNIVERSITY JAIPUR RAJASTHAN 
 
Primary Sponsor  
Name  NATIONAL INSTITUTE OF AYURVEDA DEEMED TO BE UNIVERSITY 
Address  NATIONAL INSTITUTE OF AYURVEDA DEEMED TO BE UNIVERSITY NEAR JORAWER SINGH GATE AMER ROAD JAIPUR RAJASTHAN 
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 Puja Agarwal  National Institute of Ayurveda hospital  Room no 1,7,18,22,25., Department of Kayachikitsa National Institute of Ayurveda Deemed to be University jorawar singh gate amer road Jaipur Rajasthan
Jaipur
RAJASTHAN 
9587848547

agarwalpuja2394@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Of National Institute of Ayurveda Deemed to be University Jaipur Rajasthan  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L209||Atopic dermatitis, unspecified. Ayurveda Condition: VICARCIKA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Navaka Kshaya, Reference: chakradutt-kushtha chikitsa(50/58), Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 6 Weeks, anupAna/sahapAna: No, Additional Information: Nil
(2) Medicine Name: Manjisthadi Taila, Reference: Yogratnakar Kushthachikitsa-tailrogadhikar-1, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 6 Weeks, anupAna/sahapAna: No, Additional Information: DOse may be adjusted as per the size of lesion
2Comparator Arm (Non Ayurveda)-1.Betamethsone 0.1% and 2.Tab Hydroxyzine1. Dose- according to the size of lesion dose form- cream base route of administration-Local Application Time of administration- Twice a day Duration - 6 weeks 2.Dose- 25mg dose form- Tablet route of administration-Oral Time of administration- SOS Duration - 6 weeks
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients age between 18-60 years
Patients of either sex
Patients having any signs and symptoms of Vicharchika (Eczema) like Vaivarnyata (Discolouration) Rukshata (Dryness) Kandu (pruritis) Rajii (Thickening of skin)
Patients having chronicity less than 5 years 
 
ExclusionCriteria 
Details  Patients with Steroid and cytotoxic treatment(>5 years).

Patient having concomitant illness( like-HIV, Malignancy, any immuno-compromised state.)

patient having associated skin disease like-vitiligo, psoriasis etc.)

Pregnant or lactating women

Patient participated in any clinical trial for last 6 months.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in the EASI Score  42 Days 
 
Secondary Outcome  
Outcome  TimePoints 
Change in Sign and Symptoms of Vicharchika with special reference to Dry Eczema and Change in the Extent of impairment in QoL by using DLQI(Dermatology Life Quality Index).
 
Baseline and 42 days after treatment. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   01/08/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

INTRODUCTION

In Ayurveda, various skin diseases have been described under the term Kushtha. Vicharchika is a type of kshudrakushtha ,characterized by skin eruption with dark discoloration, itching and profuse discharge, being involved of three doshas with the dominance of kapha acc to Acharya charak. Authors like Vagabhatta, Madhavakara and Bhavamishra do agree with him whereas Sushruta, ‘the father of surgery’ has mentioned the symptoms as dryness of the skin with intensive itching and marked thickening of skin, with the dominance of pitta. Similarly difference of opinion exists between the other texts like Kashyapa, Harita, Bhela etc, However All the authors have concluded with the fact that itching and eruption are cardinal symptoms.

Vicharchika has been included under raktapradoshaja vikara. Being a type of kustha, recurrence & chronic course is common. It is skin disease with predominance of kapha with clinical features like kandu, srava, pidika, shyavata, rookshata, raji, ruja and daha mainly in extremities. It has social impact, affects psychological status and disturb the social life due to its appearance, severe itching disturbing the routine.

NEED OF STUDY

In maximum of cases, patients come to ayurveda treatment after not getting satisfactory cure from  modern medicine, naturally by the time the disease has attend the chronic state , hence it is the need of the hour to find out safe and effective medicine for Vicharchika on a long term and here comes the role of Ayurveda.

To overcome the problem of high rate of recurrence,  this trial drug has been selected which is effective in destroying all types of kushtha as mentioned in the phalashruti of trial drugs .These drugs helps to destroy the samprapti of vicharchika (Eczema) due to its ushna virya and katu-kashaya  rasa and enchances the cure rate to the patient of vicharchika and check its recurrence.

AIM: To evaluate and compare the efficacy of “Navaka Kashaya & Manjisthadi Tail” in the management of Vicharchika w.s.r. to Dry eczema with Standard Control Drugs (Betamethasone oint. & Tab Hydroxyzine).

OBJECTIVE

·       Evaluation and comparison of effect of trial drugs  on signs and symptoms of Vicharchika with special reference to Dry Eczema.

·       Evaluation and comparison of effect of trial drugs on  EASI Score.

·       Evaluation and comparison of effect of trial drugs on Extent of  impairment in QoL by using DLQI(Dermatology Life Quality Index)

RESEARCH QUESTION

Is there any difference in effect between the trial drugs and standard control drugs in the management of Vicharchika with special reference to Dry Eczema?

HYPOTHESIS

Null Hypothesis (H0): There is no difference between the effect of  Trial drug (“Navaka Kashaya and Manjisthadi Tail”) and standard control drug(Betamethasone oint. & Tab Hydroxyzine) in the management of Vicharchika w.s.r to Dry Eczema.

Alternative Hypothesis:

(H1): There is  difference between the effect of trial drug( “Navaka Kashaya and Manjisthadi Tail”)  and standard control drug (Betamethasone oint. &tab Hydroxyzine)  in the management of Vicharchika w.s.r. to Dry Eczema.


 
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