| CTRI Number |
CTRI/2025/03/083559 [Registered on: 27/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of the Yavaksharadi Vati and Vachadi Kwath Kavala in the Management of Tundikeri w.s.r to Tonsillitis. |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of Yavaksharadi vati and Vachadi kwath kavala in the management of Tundikeri w.s.r. to 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 Yamini Vashishtha |
| Designation |
PG Scholar |
| Affiliation |
Mansarovar Ayurvedic Medical College Hospital and Research Centre |
| Address |
Fourth Floor room no. 2, Department of Shalakya Tantra,
Mansarovar Ayurvedic Medical College Hospital and Research
Centre Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH
462042
India
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
07089437464 |
| Fax |
|
| Email |
vashishthadryamini8585@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shubhangi Lohakare |
| Designation |
Professor |
| Affiliation |
Mansarovar Ayurvedic Medical College Hospital and Research Centre |
| Address |
Fourth Floor room no. 2, Department of Shalakya Tantra,
Mansarovar Ayurvedic Medical College Hospital and Research
Centre Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH
462042
India
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
09890698452 |
| Fax |
|
| Email |
shindeshubh84@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubhangi Lohakare |
| Designation |
Professor |
| Affiliation |
Mansarovar Ayurvedic Medical College Hospital and Research Centre |
| Address |
Fourth Floor room no. 2, Department of Shalakya Tantra,
Mansarovar Ayurvedic Medical College Hospital and Research
Centre Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH
462042
India
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
09890698452 |
| Fax |
|
| Email |
shindeshubh84@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mansarovar Ayurvedic Medical College Hospital and Research Centre,Bhopal Madhya Pradesh 462042 India |
|
|
Primary Sponsor
|
| Name |
Mansarovar Ayurvedic Medical College Hospital and Research Centre |
| Address |
Fourth Floor,Room no. 2, Department of Shalakya Tantra,
Mansarovar Ayurvedic Medical College Hospital and Research
Centre,Bhopal Madhya Pradesh
MADHYA PRADESH 462042 India
Bhopal
MADHYA PRADESH |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Yamini Vashishtha |
Mansarovar Ayurvedic Medical College Hospital and Research Centre,Bhopal |
Fourth Floor room no. 2, Department of Shalakya Tantra,
Bhopal Madhya Pradesh 462042 India
Bhopal
MADHYA PRADESH |
07089437464
vashishthadryamini8585@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee Mansarovar Ayurvedic Medical College Hospital and Research Centre Bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J039||Acute tonsillitis, unspecified. Ayurveda Condition: TUNDIKERI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yavaksharadi vati, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Procedure | - | kavalaH, कवलः | (Procedure Reference: Sharangdhar Samhita, Procedure details: Liquid filled in mouth to such a level so that it can be moved easily.It should be done twice a day.)
(1) Medicine Name: Vachadi Kwath, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 200(ml), Frequency: bd, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient with sign & symptoms of Tundikeri(Tonsillitis) described as per Ayurveda and modern science ,Patient of age 12-60 Years irrespective of gender ,Patient with 2 or more symptoms of Tonsillitis.
|
|
| ExclusionCriteria |
| Details |
Patients with peritonsillar abscess, tonsillar cyst, tonsillolith, Follicular Tonsillitis,Other conditions which mimic tonsillitis e.g. diphtheria, herpes etc,Cases which required surgical intervention ,Patients with K/C/O HIV, TB, and Hep B were excluded |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The effect of Yavaksharadi vati and Vachadi kwath kavala in Tundikeri |
7days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study Tundikeri and Tonsillitis and to study the mode of action of Yavaksharadi vati and Vachadi kwath kavala. |
7days |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
16/04/2025 |
| 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="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
|
Total 60 patients will be randomly selected and divided into 3 groups one group will be treated with Yavaksharadi vati, second group will be treated with Vachadi kwath kavala and third group will be treated with both Yavaksharadi vati and Vachadi kwath kavala in the mangenment of Tundikeri . To study deeply about Tonsillititis according to Modern science and Tundikeri according to Samhitas. Tonsils play a significant role in the immune system. Yavaksharadi vati could be a better option for the patients as we can give this vati in the form of Lozenges, which is convenient to take in this busy lifestyle. |