| CTRI Number |
CTRI/2026/03/106149 [Registered on: 13/03/2026] Trial Registered Prospectively |
| Last Modified On: |
12/03/2026 |
| 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
|
A Study Comparing Tejovatyadi Gutika and Khadiradi Gutika for the Treatment of Sore Throat. |
|
Scientific Title of Study
|
A Randomized Controlled Trial to evaluate the efficacy of Tejovatyadi Gutika Mukha-Dharan and Khadiradi Gutika Mukha-Dharan in Galagraha. |
| 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 Piyush Manoj Aloni |
| Designation |
MS Scholar Shalakyatantra (Ayurveda) |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
OPD No 8, Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune, Maharashtra
Pune
MAHARASHTRA
411028
India |
| Phone |
9518745172 |
| Fax |
|
| Email |
alonipiyush@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shamli Shailendrakumar Pawase |
| Designation |
Associate Professor Shalakyatantra |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
OPD No 8, Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune, Maharashtra
Pune
MAHARASHTRA
411028
India |
| Phone |
9028185356 |
| Fax |
|
| Email |
zinjad46@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shamli Shailendrakumar Pawase |
| Designation |
Associate Professor Shalakyatantra |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
OPD No 8, Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune, Maharashtra
Pune
MAHARASHTRA
411028
India |
| Phone |
9028185356 |
| Fax |
|
| Email |
zinjad46@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune, Maharashtra 411028 |
|
|
Primary Sponsor
|
| Name |
Sane Guruji Arogya Kendra |
| Address |
OPD No 8, Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune, Maharashtra 411028 |
| 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 Piyush Manoj Aloni |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya |
OPD No 8, Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune, Maharashtra 411028
Pune
MAHARASHTRA |
9518745172
alonipiyush@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAMs SSAM and Sane Guruji Arogya Kendra Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J029||Acute pharyngitis, unspecified. Ayurveda Condition: GALAGRAHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Tejovatyadi Gutika, Reference: Vruddha Yog Tarang, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Gutika Mukha Dharan | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Khadiradi Gutika, Reference: Yog Ratnakar, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Gutika Mukha Dharan |
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients of age group 19 to 60 years, irrespective of their
gender, religion, occupation and socio-economic status.
2) All patients having signs and symptoms of Galagraha as
follows
i. Kantha-shopha (Oedema of Oro-pharynx)
ii. Kantha-kandu (Itching in Oro-pharynx)
iii. Aaraktata (Congestion of posterior pharyngeal
wall) |
|
| ExclusionCriteria |
| Details |
1) Patients having moderate to high grade fever, having body temperature of greater than 100F.
2) Patients suffering from complications like para-tonsillar abscess (quinsy), parapharyngeal abscess and other deep neck space infections.
3) Patients diagnosed with malignancies of pharynx and oral cavity or systemic illness like Tuberculosis and other lower respiratory tract infections.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Symptoms like Kantha-shopha (Oedema of Oro-pharynx), Kantha-kandu (Itching in Oro-pharynx), Aaraktata (Congestion of posterior pharyngeal wall) will be decreased
|
Follow up on 3rd and 7th day. Observational follow up on 14th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
15/04/2026 |
| 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="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Galagraha described in Ayurveda is a throat disorder characterized by pain, irritation, inflammation, and difficulty in swallowing, which clinically resembles acute pharyngitis. Mukha-Dharan (holding medicated formulations in the oral cavity) is an important local therapeutic procedure used in the management of throat diseases. Tejovatyadi Gutika and Khadiradi Gutika are classical Ayurvedic formulations known for their anti-inflammatory, antimicrobial, and soothing properties and are commonly used in throat disorders.
The present study is planned as a randomized controlled clinical trial to evaluate and compare the efficacy of Tejovatyadi Gutika Mukha-Dharan and Khadiradi Gutika Mukha-Dharan in the management of Galagraha. Patients fulfilling the diagnostic criteria will be randomly divided into two groups and treated with the respective interventions. Clinical parameters such as throat pain, dysphagia, irritation, and congestion will be assessed before and after treatment. The results will be analyzed statistically to determine the effectiveness of both therapies and their comparative efficacy in relieving the symptoms of Galagraha. |