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CTRI Number  CTRI/2025/04/085290 [Registered on: 21/04/2025] Trial Registered Prospectively
Last Modified On: 21/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing Sindooradhya and Vachadi Ointments for Treating Scabies in School Children 
Scientific Title of Study   Comparative Evaluation of Efficacy of Modified form of Sindooradhya Taila (Ointment) vs Vachadi Ointment the management of Scabies (Pama) in school-going children:A Randomized clinical trial 
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 Tushar Subhash Nandanwar 
Designation  PG Scholar 
Affiliation  Mahatma Gadhi Ayurved college Hospital and Research centre 
Address  Room No 41 Department of kaumarbhritya Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod Hirapur Wardha Wardha MAHARASHTRA 442001 India

Wardha
MAHARASHTRA
4420001
India 
Phone  9511749162  
Fax    
Email  Tushar1347@outlook.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rahul M Jumle 
Designation  Associate Professor 
Affiliation  Mahatma Gandhi Ayurveda College Hospital and Research Centre 
Address  Room No 41 Department of kaumarbhritya Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod Hirapur Wardha Wardha MAHARASHTRA 442001 India

Wardha
MAHARASHTRA
4420001
India 
Phone  9766643990  
Fax    
Email  rahul.jumle@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Tushar Subhash Nandanwar 
Designation  PG Scholar 
Affiliation  Mahatma Gandhi Ayurveda College Hospital and Research Centre 
Address  Room No 41 Department of kaumarbhritya Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod Hirapur Wardha Wardha MAHARASHTRA 442001 India

Wardha
MAHARASHTRA
4420001
India 
Phone  9511749162  
Fax    
Email  Tushar1347@outlook.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Ayurveda College Hospital and Research Centre Hirapur Salod, Wardha, Maharashtra, India 442001 
 
Primary Sponsor  
Name  Mahatma Gandhi Ayurveda College Hospital and Research Centre 
Address  Room No 41 Department of Kaumarbhritya Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod Hirapur, Wardha, Maharashtra, India 442001 
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 Tushar Subhash Nandanwar  Mahatma Gandhi Ayurved College Hospital And Research Centre Salod Wardha  Room no 41 department of kaumarbhrutya Mahatma Gandhi Ayurved College Hospital And Research Centre Salod Wardha Wardha MAHARASHTRA
Wardha
MAHARASHTRA 		 9511749162

Tushar1347@outlook.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Mahatma Gandhi Ayurved College Hospital and Research Centre Institutional Ethics Committee Salod Wardha  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:B86||Scabies. Ayurveda Condition: PAMA (KACCU),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Vachadi Ointment, Reference: सु. चि. २०।१८, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Sindooradhya Ointment, Reference: ग. नि.।कुष्ठा. ३६, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  Patient willing to give written informed consent with either gender having age of 05 to 16 years and patients Parents willing to allow their child to participate with Clinically diagnosed Pama (Scabies) 
 
ExclusionCriteria 
Details  Patients who have had a long-term Pama Kushtha infection and with additional skin conditions and Having serious systemic illnesses such as HIV TB systemic lupus erythematosus 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of Sindooradhya ointment in Pama (Scabies) in Children of 5 year to 16 years by gradation scale parameter with number and size of patches  at 7th, 15th days 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of Vachadi ointment in Pama (Scabies) in Children of 5 year to 16 years by gradation scale parameter with number and size of patches  at 1st , 2nd week 
 
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/ Phase 4 
Date of First Enrollment (India)   11/05/2025 
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="2"
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  

the volunteers will be informed about the study protocol. Willing participants will be randomly selected as per computer generated table. Clinical research format will be prepared and validated. Prior to the study approval will be taken from IEC, MGACHRC, Salod (H) Wardha and CTRI registration will be done. After selection, each participant will be tested individually and selected according to selection criteria. They are divided into two groups the trial is a Randomized standard Control Superiority Clinical Trial. it will include a 14 days treatment period and after 14 days follow-up period.

 
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