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CTRI Number  CTRI/2025/02/080995 [Registered on: 20/02/2025] Trial Registered Prospectively
Last Modified On: 12/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effectiveness of intervention Nimbanilavakadi kashaya in participants having Contact Dermatitis 
Scientific Title of Study   Effectiveness of internal and external administration of nimbanilavakadi kwatha in contact dermatitis. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  GAYATHRI R 
Designation  PG SCHOLAR 
Affiliation  Government Ayurveda College Thiruvananthapuram 
Address  Department of Agadatantra Government Ayurveda College Panchakarma Hospital Poojappura Thiruvananthapuram kerala 695012 India

Thiruvananthapuram
KERALA
695012
India 
Phone  6282245584  
Fax    
Email  gayathri.rth@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shiji R S 
Designation  Professor and HOD 
Affiliation  Government Ayurveda College Thiruvananthapuram 
Address  Department of Agadatantra Government Ayurveda College Panchakarma Hospital Poojappura Thiruvananthapuram kerala 695012 India

Thiruvananthapuram
KERALA
695012
India 
Phone  9446591947  
Fax    
Email  drshijirs@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shiji R S 
Designation  Professor and HOD 
Affiliation  Government Ayurveda College Thiruvananthapuram 
Address  Department of Agadatantra Government Ayurveda College Panchakarma Hospital Poojappura Thiruvananthapuram kerala 695012 India

Thiruvananthapuram
KERALA
695012
India 
Phone  9446591947  
Fax    
Email  drshijirs@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda College Thiruvananthapuram Kerala India 695001 
 
Primary Sponsor  
Name  Government Ayurveda College Thiruvananthapuram 
Address  Gayathri R Department of Agadatantra Government Ayurveda College Thiruvananthapuram Kerala India 695001 
Type of Sponsor  Other [Government Ayurveda College Thiruvananthapuram] 
 
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 
Gayathri R  Government Ayurveda College Panchakarma Hospital   Government Ayurveda College Panchakarma Hospital OP no 3 Department of Agadatantra Poojappura 695012 Thiruvananthapuram Kerala
Thiruvananthapuram
KERALA 		 6282245584

gayathri.rth@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE(IEC) GOVERNMENT AYURVEDA COLLEGE TRIVANDRUM KERALA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L258||Unspecified contact dermatitis dueto other agents. Ayurveda Condition: GARAVISHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Nimbanilavakadi kwatha, Reference: pharmacopeia of Government Ayurveda College Trivandrum, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Nimbanilavakadi kwatha, Reference: Pharmacopeia of Government Ayurveda College Trivandrum, Route: Topical, Dosage Form: Kwatha/ Kashaya, Dose: 500(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Participants having history of exposure to
cement.
2. Participants presenting with symptoms of
contact dermatitis – erythema, pruritis,
papules, excoriation and lichenification.
3. Participants within the age limit of 18-60yrs.
4. Cases with duration of symptoms of contact
dermatitis due to cement not more than 1yr.
 
 
ExclusionCriteria 
Details  1. Participants with uncontrolled diabetes mellitus and hypertension.
2. Participants under steroidal medication.
3. Participants having known history of drug allergy.
4. Pregnant and lactating women.
5. Participants having symptoms of contact dermatitis due to contactants other than cement.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Changes in the assessment parameters – erythema, papules, excoriation, lichenification and pruritis.  Changes in the assessment parameters – erythema, papules, excoriation, lichenification and pruritis at baseline, 7th day, 14th day and 21st day. 
 
Secondary Outcome  
Outcome  TimePoints 
N/A  N/A 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   25/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  25/02/2025 
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   Contact dermatitis is a common complaint in people of all ages, in part because of the large no of potential irritants and allergens in the contemporary environment. Cement is one of the most important cause of occupational disease in construction workers. In context of Agadatantra, Acharya Susrutha mentions different types of contact poisoning in Kalpasthana- like abharana visha, paduka visha, abhyanga visha, anulepana visha etc which is similar in manifestation to contact dermatitis.The allopathic management of contact dermatitis mainly involve the use of topical steroids which gives only short term relief and the repeated use of which may cause several side effects including skin atrophy. Eventhough the treatment of contact poisons are described in susrutha samhitha kalpasthana,  a common treatment protocol for the symptoms of contact poisons is not available. So an attempt is made to use one of the vishahara formulation mentioned in the Ayurveda pharmacopeia of Government Ayurveda college Trivandrum used among the visha practitioners in kerala.  
Nimbanilavakadi kwatha is one such formulation available in the pharmacopeia of Govt Ayurveda College Thiruvananthapuram, used by visha practitioners of kerala in treatment of vishavikaras. It contains few medicines which are easily available and economical.    
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