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CTRI Number  CTRI/2024/07/069830 [Registered on: 02/07/2024] Trial Registered Prospectively
Last Modified On: 15/01/2026
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   To Assess the efficacy of Laghumanjisthadi Kashaya and Mahatrinaka Taila in Eczema Management  
Scientific Title of Study   Randomized controlled trial to evaluate the efficacy of Laghumanjisthadi kashaya and Mahatrinaka Taila in the management of Vicharchika W.S.R to Eczema  
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 Neha Agrawal  
Designation  PG Scholar  
Affiliation  National Institute of Ayurveda, Deemed to be university, Jaipur  
Address  Department of Kayachikitsa, National Institute of Ayurveda, Deemed to be university, Near Jorawar Singh gate, Amer road Jaipur Rajasthan 302002 India

Jaipur
RAJASTHAN
302002
India 
Phone  9549232949  
Fax    
Email  agrawalneha1559@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pravin Shamrao Sawant  
Designation  Associate Professor  
Affiliation  National Institute of Ayurveda, Deemed to be university, Jaipur  
Address  Department of Kayachikitsa, National Institute of Ayurveda, Deemed to be university, Near Jorawar Singh gate, Amer road Jaipur Rajasthan 302002 India

Jaipur
RAJASTHAN
302002
India 
Phone  9890275426  
Fax    
Email  drsawantps@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pravin Shamrao Sawant  
Designation  Associate Professor  
Affiliation  National Institute of Ayurveda, Deemed to be university, Jaipur  
Address  Department of Kayachikitsa, National Institute of Ayurveda, Deemed to be university, Near Jorawar Singh gate, Amer road Jaipur Rajasthan 302002 India


RAJASTHAN
302002
India 
Phone  9890275426  
Fax    
Email  drsawantps@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda, Deemed to be university, Jaipur  
 
Primary Sponsor  
Name  National Institute of Ayurveda, Deemed to be university, Jaipur  
Address  Department of Kayachikitsa, National Institute of Ayurveda, Deemed to be university, Near Jorawar Singh gate, Amer road Jaipur Rajasthan 302002 India 
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 Neha Agrawal   Hospital, National Institute of Ayurveda, Deemed to be university, Jaipur   OPD No 1, 18, 22, 25 Hospital, Department of Kayachikitsa, National Institute of Ayurveda, Deemed to be university, Near Jorawar Singh gate, Amer road Jaipur Rajasthan 302002 India
Jaipur
RAJASTHAN 		 9549232949

agrawalneha1559@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics comittee National Institute of Ayurveda Deemed to be university (De-Novo)(Ministery of Ayush Govt of India )Jorawar singh gate amer road jaipur 302002  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: Laghumanjisthadi kashaya , Reference: Yoga Tarangini , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: -
(2) Medicine Name: Mahatrinaka Taila, Reference: Vrinda Madhava , Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: sos, Bhaishajya Kal: Muhurmuhu, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator Arm (Non Ayurveda)-Tab FEXOFENADINE and ointment Glycerin Tab FEXOFENADINE Dose : 180 mg Dose form : Tablet Route of administration: Oral Time of administration : OD Duration of Therapy : 4 weeks Ointment Glycerin Dose : According to size of lesion Dose form : Cream Base Route of administration : Local application Time of administration : Twice in a day Duration of Therapy : 4week
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients age between 18-60 years, irrespective of sex.
2. Patients having clinical signs and symptoms of Eczema like pruritis, oozing, Eruptions,
Discoloration, Dryness, Thickening of skin.
3. Patients having chronicity less than 5 years 
 
ExclusionCriteria 
Details  1. Patients below the age of 18 years and above 60 years.
2.Patients with Steroid and cytotoxic treatment greater than 5 years
3.Patient having concomitant illness like HIV, Malignancy.
4.Pregnant or lactating women.
5.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 
changes in EASI score from the baseline value after Four weeks  At baseline and after 4 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
changes in following parameters-
• Change in intensity of itching, roughness of skin, oozing from lesion site , skin
eruptions, skin discoloration from the baseline value after 4 weeks.
• Change in QOL using DLQI ( Dermatology Life Quality Index) 		 At baseline and end of 28 days treatment  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 3 
Date of First Enrollment (India)   01/08/2024 
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="28" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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  
The skin is the largest organ of the human body which is related to visual clinical speciality. skin is envelop of internal structure, which protects us against mechanical, chemical and biological hazards.  Now a  days, a Gradual increase in the prevalence of Vicharchika (Eczema) has been observed at general OPD level. The whole world is turning towards Ayurveda. Ayurveda has a lot to offer in this regard. so as vaidhya it’s our duty to help society as much as we can do. So that’s why vicharchika is chosen as a topic for research. Vicharchika has been correlated with eczema which has tendency of exacerbation and follows a chronic relapsing & remitting course.  So it is the need of the hour to find out safe and cost effective medicine for Vicharchika on a long term and here comes the role of Ayurveda. Therefore, keeping all these facts in mind, it has been decided to conduct a clinical study entitled as“A RANDOMISED CONTROLLED TRIAL TO EVALUATE THE EFFICACY OF LAGHUMANJISHTHADI KASHAYA AND MAHA TRINAKA TAILA IN THE MANAGEMENT OF VICHARCHIKA W.S.R. TO ECZEMA.


Aim:  To evaluate the efficacy of “Laghumanjishthadi Kashaya and Mahatrinaka Taila in the management of Vicharchika w.s.r. to Eczema.

Objectives :

Primary objective: To study the effect of Laghumanjisthadi Kashaya and Mahatrinaka Taila on EASI score.

Secondary objectives: To study the effect of Laghumanjisthadi Kashaya and Mahatrinaka Taila in the Erythema, Dryness, Itching, Scaling, Discoloration, Oozing.

Null hypothesis[H0] : There is no difference in treatment outcome between the trial drug (“Laghumanjishthadi Kashaya and Mahatrinaka Tail”) and conventional first line drugs (Glycerin ointment & Tab Fexofenadine) in the management of Vicharchika w.s.r. to Eczema.

Alternative hypothesis[H1] :  There is difference in treatment outcome between trial drug( “Laghumanjishthadi Kashaya and Mahatrinaka Taila”) and conventional first line drugs (Glycerin ointment & tab Fexofenadine) in the management of Vicharchika w.s.r. to Eczema.

Study design : Phase of clinical study : Phase 2; Study type : Intervention, Single Centre, Randomized, Open label, Timing : Prospective,  Number of groups :two; Number of patients : 60 , Duration of study : 28 days( 4 weeks) .

The information gathered through observation will be used for statistical analysis in terms of Mean, Standard Deviation and Standard error (SE). For intra-group assessment, Wilcoxon matched – pairs signed Ranks test will be used for non – parametric data & for parametric data Paired ‘t-test’ will be used and results will be calculated. For inter-group comparisons, for the Non parametric variables Mann-Whitney Test will be used while for Parametric variables Unpaired ‘t’ Test will be used for statically analysis.


 
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