| CTRI Number |
CTRI/2026/03/105205 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
28/02/2026 |
| 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
|
Clinical Evaluation of Darvi Raskriya kawal in reducing the symptoms of redness of pharyngeal tonsil, throat pain ,size, post nasal discharge in the treatment of Gilayu (Acute Tonsillitis) |
|
Scientific Title of Study
|
Randomised Controlled Clinical Trial to Determine the Efficacy of Darvi raskriya kawal in the management of Gilayu w.s.r. to A. Tonsillitis |
| 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 Pratiksha Premdas Rathod |
| Designation |
PG scholar |
| Affiliation |
SST Ayurved Mahavidyalaya,Sangamner |
| Address |
Department of shalakyatantra ,SST Ayurved Mahavidyalaya,Sangamner, Nashik Pune road,opposite to Prasad hotel,Dist Ahmadnagar
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9359969546 |
| Fax |
|
| Email |
drpratiksharathod1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amol Walzade |
| Designation |
Associate Professor |
| Affiliation |
SST Ayurved Mahavidyalaya,Sangamner |
| Address |
Department of shalakyatantra,SST Ayurved Mahavidyalaya,Sangamner,Nashik Pune road,opposite to Prasad hotel,Dist Ahmadnagar
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9823553070 |
| Fax |
|
| Email |
dramolwalzade@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amol Walzade |
| Designation |
Associate Professor |
| Affiliation |
SST Ayurved Mahavidyalaya,Sangamner |
| Address |
Department of Shalakyatantra,SST Ayurved Mahavidyalaya,Sangamner,Nasik Pune road,opposite to Prasad hotel,Dist Ahmadnagar
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9823553070 |
| Fax |
|
| Email |
dramolwalzade@gmail.com |
|
|
Source of Monetary or Material Support
|
| SST Ayurved Mahavidyalaya Sangamner Nashik Pune road opposite to prasad hotel Dist Ahmadnagar Maharashtra India 422605 |
|
|
Primary Sponsor
|
| Name |
Dr Pratiksha Premdas Rathod |
| Address |
Department of Shalakyatantra SST Ayurved Mahavidyalaya Sangamner Nashik Pune road opposite to Prasad hotel Dist Ahmadnagar Maharashtra India 422605 |
| Type of Sponsor |
Other [Self] |
|
|
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 Pratiksha Premdas Rathod |
SST Ayurved Mahavidyalaya and hospital,Sangamner |
Opd no 3,Department of Shalakyatantra,SST Ayurved Mahavidyalaya,Sangamner,Nashik Pune road,opposite to Prasad hotel,Dist Ahmadnagar
Ahmadnagar
MAHARASHTRA |
9359969546
drpratiksharathod1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee SST Ayurved Mahavidyalaya Sangamner |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J039||Acute tonsillitis, unspecified. Ayurveda Condition: GILAYUH/GILAYUKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | kavalaH, कवलः | (Procedure Reference: Ashtangsangraha, Procedure details: 10 gm of Darvi raskriya mixed with 1 glass of warm water. Patient is seated comfortably in an upright position. Prepared solution given to the patient as kawal Dravya for gargling and holding in the oral cavity till salivation (2 times a day for 14 days))
(1) Medicine Name: Darvi raskriya , Reference: Charak sanhita chikitsasthan 26/202, Route: Topical, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: bd, Duration: 14 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Betadine solution | Drug -Betadine solution, Route of administration-Topical oral route, Dose-10ml in 1 glass of warm water 2 times a day ,Duration of treatment-14 days with follow up on 7th and 14th day |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient between age 18-50 yrs
2.Patients with clinical symptoms (redness of pharyngeal tonsil, swelling, throat pain from 4 to 6 days but not more than 2 weeks.
3.selections of Patients will be irrespective of their sex, religion, Socioeconomic Status
4. No history of allergies to Betadine or herbal ingredients.
5. Is willing to provide informed consent and adhere to the treatment.
6.Tonsilar Hypertropy, throat pain during swallowing as cardinal symptoms must be present in patient
|
|
| ExclusionCriteria |
| Details |
1. Patient who had peritonsilar abcess, pus pocket, quinsy, laryngeal oedema, para pharyngeal abscess, septicemia, high grade fever are excluded from the Study
2. Patients Suffering from any other systemic disorders like DM, HTN, diseases of oral-Cavity.
3. Allergic history to herbal or Betadine formulations
4. Pregnant, lactating mothers.
5.patient who will be any other medication for the same symptoms will be not taken for the study. |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in sign and symptoms redness of pharyngeal tonsil, throat pain,size,post nasal discharge |
Total duration of treatment- 2 weeks
Assessment on 1st,2nd week
Post treatment follow up-3rd week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
N/A |
|
Date of First Enrollment (India)
|
18/03/2026 |
| 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
|
TITLE-Randomized controlled Clinical Trial to Determine the Efficacy of Darvi Raskriya kawal in the Management of Gilayu W.S.R to A. Tonsillitis
INTRODUCTION- Gilayu is one of the kanthagat roga described by Aacharya Sushrut. which can be Compared with A. Tonsillitis in modern Science.Sushrut described kantgat roga under mukhroga in Nidansthan instead of uttarsthan. Sushruta has described tonsillitis (Gilayu) as a glandular swelling in the throat, vitiation of Kapha Rakta, less painful and like a Amalaki seed. shastrakarma sadhya-shastrakarma-chedan. Tonsils, a set of lymph nodes glands. Present in the entry of oral cavity one each on either side are a part of lymphatic and immune system. Tonsils are the main part of immune system whenever there is an infection in the oral Cavity or upper respiratory track, tonsils Plays first role in defence mechanism to Prevent the infections Tonsillitis is inflammations of Pharyngeal tonsils.Tonsillitis is of two types Acute & Chronic, In Acute there is Sore throat, dysphagia, earache. Throat examination reveal hyperemia of Piller, soft Palate & uvula . Aacharya charak mentioned the kawal of darvi raskriya mixed with honey which is easily available and effective treatment for Gilayu. In Maharshtra, the Prevalance rate of A, Tonsillitis is 11.6%
SAMPLE SIZE- Total sample size for study will be 80 participants divided equally between trial and control group.
NULL HYPOTHESIS (H0)- Darvi raskriya kawal is not significantly effective in the management of Gilayu w.s.r A.Tonsillitis
ALTERNATE HYPOTHESIS (H1)- Darvi raskriya kawal is significantly effective in the management of Gilayu w.s.r A. Tonsillitis
|