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CTRI Number  CTRI/2025/09/094719 [Registered on: 12/09/2025] Trial Registered Prospectively
Last Modified On: 12/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To see the effect of Shaivaladi Tail Karnapichu and Samudraphena Avachurnan in Karnasrava(Tubo-tympanic type of CSOM) 
Scientific Title of Study   Comparative Clinical Evaluation of Shaivaladi Tail Karnapichu and Samudraphena Avachurnan in Karnasrava(Tubo-tympanic type of CSOM) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Charvi Verma 
Designation  PG Scholar 
Affiliation  Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan 
Address  OPD 3, Department of Shalakya Tantra, Patanjali Ayurved Hospital, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Phase 1, Roorkee road, Haridwar, Uttarakhand, India 249405

Hardwar
UTTARANCHAL
249405
India 
Phone  8445385986  
Fax    
Email  charviverma2897@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Jyoti Gupta  
Designation  Professor 
Affiliation  Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan 
Address  OPD 3, Department of Shalakya Tantra, Patanjali Ayurved Hospital, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Phase 1, Roorkee road, Haridwar, Uttarakhand, India 249405

Hardwar
UTTARANCHAL
249405
India 
Phone  9997907340  
Fax    
Email  jyotiguptania@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Jyoti Gupta  
Designation  Professor 
Affiliation  Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan 
Address  OPD 3, Department of Shalakya Tantra, Patanjali Ayurved Hospital, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Phase 1, Roorkee road, Haridwar, Uttarakhand, India 249405


UTTARANCHAL
249405
India 
Phone  9997907340  
Fax    
Email  jyotiguptania@gmail.com  
 
Source of Monetary or Material Support  
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, yogpeeth Phase 1, Haridwar, Uttarakhand, India 249405 
 
Primary Sponsor  
Name  Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan. Haridwar 
Address  Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, yogpeeth Phase 1, Haridwar, Uttarakhand, India 249405 
Type of Sponsor  Private medical college 
 
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 Charvi Verma  Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan  OPD 3, Department of Shalakya Tantra, Patanjali Ayurved Hospital, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Phase 1, Roorkee road, Haridwar
Hardwar
UTTARANCHAL 		 8445385986

charviverma2897@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H661||Chronic tubotympanic suppurative otitis media. Ayurveda Condition: KARNA-SRAVAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-avacUrNan  , अवचूर्णन  (Procedure Reference: Sushrut Samhita, Procedure details: A pinch of finely powdered Samudraphena will be sprinkled in the ear canal once a day. )
(1) Medicine Name: Samudraphena Churna, Reference: Yogaratnakar, Route: Otic, Dosage Form: Churna/ Powder, Dose: 100(mg), Frequency: od, Duration: 7 Days
2Intervention ArmProcedure-Karnapichu (Procedure Reference: Ashtang Hridayam, Procedure details: A wick of cotton swab is dipped in Shaivaladi Tail & kept in ear canal for 3-4 hours once a day.)
(1) Medicine Name: Shaivaladi Tail, Reference: Sushrut Samhita Uttartantra 21-45, Route: Otic, Dosage Form: Taila, Dose: 1(ml), Frequency: od, Duration: 7 Days
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients with age group of 10 years to 70 years.
2. Patients presenting with sign and symptoms of Tubo tympanic type of CSOM.
3. Patient willing to participate in this trial through written consent.  
 
ExclusionCriteria 
Details  1. Patients below 10 years and above 70 years of age.
2. Pregnant women and lactating mothers.
3. Patient suffering with systemic diseases like Diabetes Mellitus (Type I and II ), Meningitis, Tuberculosis.
4. Patients with Attico antral type of CSOM .
5. Patients with the complications of CSOM like Mastoiditis, Subdural Abscess,Extradural Abscess , Labyrinthitis, Vertigo .
6. Patients with Otomycosis. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Ear Discharge
2. Pain in ear
3. Itching in ear
4. Tinnitus 		 0,3 weeks ,6 weeks,8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Objective parameter will be assessed-
1. Hearing loss 		 0,3 weeks,6 weeks,8 weeks 
 
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)   27/09/2025 
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="8"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Research Articles , Thesis

  6. For how long will this data be available start date provided 10-10-2026 and end date provided 02-02-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   In this trial, we are selecting the patients of Karnasrava in which we will do the intervention in 2 groups - 30 patients in each group. In one group, we will intervene with ayurvedic therapeutic procedure of karnapichu with shaivaladi tail once daily in two sittings of 7-7 days with 7 days gap in between, whereas in other group we will intervene with another ayurvedic therapeutic procedure of avachurnan with Samudraphena once daily in two sittings of 7-7 days with 7 days gap in between. First follow-up will be on 15th day after the completion of treatment and second follow-up will be after 15 days of first follow-up. Assessment will be done on the basis of subjective and objectives parameters and scoring will be done before and after the treatment.  
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