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CTRI Number  CTRI/2025/05/087012 [Registered on: 15/05/2025] Trial Registered Prospectively
Last Modified On: 14/05/2025
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   Comparing the clinical efficacy of tiktashatpalaka ghrita ointment alone externally with tiktashatpalaka ghrita internally and its ointment externally in eczema. 
Scientific Title of Study   Pharmaceutical standardization of Tiktashatpalaka Ghrita and its comparative clinical efficacy administered internally with its external application (ointment) and only external application in the management of Vicharchika (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  Smruti Sikha Behera 
Designation  MD Scholar 
Affiliation  Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat 
Address  Department of Rasashastra and bhaisajya kalpana 2nd floor Academic Building Institute of Teaching and Research in Ayurveda, Gurudwara Road, Jamnagar, Gujarat-361008, India

Jamnagar
GUJARAT
361008
India 
Phone  9337056592  
Fax    
Email  smrutisikhabehera34@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof BJ Patgiri 
Designation  Professor and HOD  
Affiliation  Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat 
Address  Department of Rasashastra and bhaisajya kalpana 2nd floor room no. 204 Academic Building Institute of Teaching and Research in Ayurveda, Gurudwara Road, Jamnagar, Gujarat-361008, India

Jamnagar
GUJARAT
361008
India 
Phone  9426947438  
Fax    
Email  patgiri124@gmail.com  
 
Details of Contact Person
Public Query  
Name  Smruti Sikha Behera 
Designation  MD Scholar 
Affiliation  Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat 
Address  Department of RSBK 2nd floor Academic Building Institute of Teaching and Research in Ayurveda, Gurudwara Road, Jamnagar, Gujarat-361008, India

Jamnagar
GUJARAT
361008
India 
Phone  9337056592  
Fax    
Email  smrutisikhabehera34@gmail.com  
 
Source of Monetary or Material Support  
Institute of Teaching and Research in Ayurveda Opposite B Division Police Station Gurudwara Road, Jamnagar, Gujarat-361008, India  
 
Primary Sponsor  
Name  Institute of Teaching and Research in Ayurveda, Jamnagar 
Address  Opposite B Division Police Station Gurudwara Road, Jamnagar, Gujarat-361008, 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 Smruti Sikha Behera  Institute of Teaching and Research in Ayurveda Hospital  Department of RSBK Division B OPD Room. 07
Jamnagar
GUJARAT 		 9337056592

smrutisikhabehera34@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee nstitute of Teaching and Research in Ayurveda Jamnagar Gujarat  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
1Comparator ArmDrugClassical(1) Medicine Name: Tiktashatpalaka Ghrita ointment, Reference: Charaka Chikitsa 7/140-143, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 06(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 08 Weeks, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Tiktashatpalaka Ghrita and Tiktashatpalaka ointment, Reference: Charak Chikitsa 7/140-143, Route: Oral, Dosage Form: Ghrita, Dose: 06(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 08 Weeks, anupAna/sahapAna: Yes(details: -Ushna Jala), Additional Information: -In this group both internal and external application of ghrita and its ointment respectively will be given to patients.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patient having classical signs and symptoms of Vicharchika like Kandu, Vaivarnyata, Rukshata, and Srava.
2. Uncomplicated cases with classical signs and symptoms of Vicharchika will be selected
irrespective of gender, religion, and profession. 
 
ExclusionCriteria 
Details  1. Age less than 18 years and more than 60 years.
2. Pregnant and lactating women.
3. Uncontrolled Diabetes Mellitus & Hypertension.
4. Any other serious systemic illness.
5. Patients who are not willing for inclusion in the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Comparative evaluation of efficacy of Tiktashatpalaka Ghrita internally and its
ointment externally as that of only external application of its ointment in the
management of Vicharchika (eczema). 		 1.5 years 
 
Secondary Outcome  
Outcome  TimePoints 
1. Study shall generate data of evidence to evaluate add on effect of
internal administration of Tiktashatpalaka Ghrita in the patients with external
application of its ointment. 		 1.5 years 
 
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 2 
Date of First Enrollment (India)   01/06/2025 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

INTRODUCTION

The drug proposed for evaluation of comparative efficacy in the present research work is Tiktashatpalaka Ghrita, and its ointment is effective in the management of Vicharchika (eczema). But no previous scientific research work has been carried out to prove the comparative efficacy of Tiktashatpalaka Ghrita and its ointment in the management of eczema. Therefore, the present work is an attempt to test pharmaceutical variants in the management of Vicharchika (eczema).

Modern medical science has medicines for symptomatic relief for diseases like eczema, along with side effects for steroids, which are the specific treatment for eczema. So the study is planned to find out the alternative effective management of Vicharchika from ancient texts, which is cheap and effective.

Patients fulfilling the inclusion criteria will be selected from OPD & IPD ITRA, Jamnagar. Patients will be selected from the age group of 18-60 years of either sex, irrespective of religion or caste.

Details of trial procedure and drugs:

Both the trial drug (Tiktashatpalaka Ghrita and its ointment) will be prepared in the Dept. of RSBK by classical methods. A minimum of 60 patients (30 in each group) fulfilling the inclusion criteria (details mentioned in the synopsis) will be selected from the OPD & IPD of ITRA, Jamnagar, and randomly divided into 2 groups. Diagnosis will be done on the basis of signs & symptoms and investigations (if needed). A patient information sheet will be prepared, and written consent will be taken. CTRI registration will be done before starting the clinical trial.

 

Posology, duration of administration, and follow-up:

In Group A, each patient will receive Tiktashatpalaka Ghrita internally (6 g twice a day, early morning empty stomach and 2 hrs before dinner) and its ointment externally in sufficient quantity for even application (morning and evening) and In Group B, ointment of Tiktashatpalaka Ghrita externally in sufficient quantity for even application (morning and evening) will be given, and there will be a follow-up for 4 weeks.

Status of ongoing medicines and treatment:

Ongoing management of Vicharchika (Shamana, Rasayana Chikitsa) and modern treatment of eczema-like moisturizers, topical antibiotics, antihistamines, topical calcineurin inhibitors, and topical corticosteroids will be held 7 days before the commencement of treatment; systemic steroids shall be tapered off gradually, and no additional medicaments will be given. If a patient has an exacerbation of their condition in both groups during the treatment period or follow-up period, they shall be withdrawn from the study and shall be managed accordingly or referred to a concerned physician.

 

Dietary restrictions/advice: Patients will be advised to avoid aggravating factors mentioned in ancient literature.

 

Results and Statistical Analysis: Results will be assessed on the basis of improvement in subjective parameters like cardinal symptoms and objective criteria before and after treatment and at the end of the follow-up period. TLC, DLC, ESR, and Absolute Eosinophil Count (AEC) will be conducted before and after treatment and at the end of the follow-up period. The information gathered on the basis of observations made about various parameters will be subjected to statistical analysis with parameters like mean, SD, and CV. For quantitative data, paired and unpaired t-tests, and for qualitative data, the Wilcoxon signed rank test will be applied. Regression analysis will be applied.

 
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