| CTRI Number |
CTRI/2025/09/094719 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2026 |
| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | 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 | | 2 | Intervention Arm | Procedure | - | 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)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
27/09/2025 |
| Date of Study Completion (India) |
20/04/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Revisiting Karnasrava - Integrating Ayurvedic Concepts with Modern Otological Insights, Published in EPRA International Journal of Research and Development, Volume 11, Issue 4, April 2026 , Charvi Verma is the Author |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Research Articles , Thesis
- 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.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
This comparative clinical study was conducted to evaluate the efficacy of Shaivaladi Tail Karnapichu and Samudraphena Avachurnan in patients with Karnasrava (Tubo-tympanic type of CSOM). A total of 66 patients were registered, of whom 60 patients completed the study and were randomly allocated into two groups of 30 patients each. Group A received Shaivaladi Tail Karnapichu, while Group B received Samudraphena Avachurnan as per the approved treatment protocol. Assessment was carried out before and after treatment based on subjective and objective parameters. |