| CTRI Number |
CTRI/2025/02/081008 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
17/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
clinical trial to see the effect of Ayurvedic formulation in the form of oral administration in the
treatement of Galagraha with reference to acute pharyngitis
|
|
Scientific Title of Study
|
randomized controlled trial to evaluate the efficacy of Amrutprabha Gutika Dharana and
Khadiradi Gutika Dharana in Galagraha with reference to Acute Pharyngitis. |
| 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 Mayuri Ramdas Idpachi |
| Designation |
PG Scholar |
| Affiliation |
MAMS Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
OPD NO. 8 Department of Shalakyatantra, Sane Guruji Arogya
Kendra,Malwadi Road Hadapsar,Pune Pune MAHARASHTRA
411028 INDIA
Pune
MAHARASHTRA
411028
India
Pune
MAHARASHTRA
411028
India |
| Phone |
7350190914 |
| Fax |
|
| Email |
mayuriri2014@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Mrs Nilakshi S Pradhan |
| Designation |
H. O. D Shalakyatantra |
| Affiliation |
MAMS Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
OPD No 8 Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi Road Hadapsar, Pune Maharashtra 411028
Pune
MAHARASHTRA
411028
India |
| Phone |
9423580963 |
| Fax |
|
| Email |
drnspradhan@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Mrs Nilakshi S Pradhan |
| Designation |
H. O. D Shalakyatantra |
| Affiliation |
MAMS Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
OPD No 8 Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi Road Hadapsar, Pune Maharashtra 411028
Pune
MAHARASHTRA
411028
India |
| Phone |
9423580963 |
| Fax |
|
| Email |
drnspradhan@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of shalakyatantra, Sane Guruji Arogya Kendra, Malwadi, Hadapsar, Pune, Maharashtra, 411028,India |
|
|
Primary Sponsor
|
| Name |
Sane Guruji Arogya Kendra |
| Address |
OPD NO 8,Department of Shalakyatantra,Sane Guruji Arogya
Kendra,Malwadi road Hadapsar,Pune MAHARASHTRA
411028,India |
| 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 Mayuri Ramdas Idpachi |
Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar |
OPD No 8 Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi Road Hadapsar Pune Maharashtra
Pune
MAHARASHTRA |
73501 90914
mayuriri2014@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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: Amrutprabha Gutika, Reference: Yogchintamani, 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: - | | 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: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age group of 18 to 60 years, irrespective of their gender, religion, occupation
and socioeconomic status.
All patients having sign and symptoms of Galagraha (Acute Pharyngitis)
Kanthashopha (Oedema in Oro -pharyngeal region)
Kanthakandu (Itching in Oro-pharyngeal region)
Aaraktata (Posterior pharyngeal wall Congestion)
Patints without having any complications.
|
|
| ExclusionCriteria |
| Details |
Patients with complication peritonsillar abscess, parapharyngeal abscess etc.
Lower respiratory tract infected patients.
Patients having chronic condition in pharynx like carcinoma in throat region.
|
|
|
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 |
Kanthashopa, Kanthakandu, Aaraktata will be
decreased, subject will get relief from
Galagraha.
|
Kanthashopa, Kanthakandu, Aaraktata will be
decreased, subject will get relief from
Galagraha.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Subject will get relief from Jwara (Low Grade
Fever).
|
18 Months |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
20/03/2025 |
| 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="6"
Days="15" |
|
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
|
Acharya Charaka explained 4 types of Mukharoga but according to Adhishthana,Rasaraktadi Dushya,Aakruti and Naam there are 64 types of Mukharoga are mentioned by Acharya Charaka, further explains about Lakshanas of Galagraha, mentioned under Sthaniya Shothaprakaraja Roga in Sutrasthan, chapter Trishothiyaadhyay. This Disease is caused due to vitiation of Kapha Dosha which settled in Gala (Throat) produces Aashu (Rapid) Shopha (Swelling) which is Sthira (stable) in nature. According to Kashyapa Samhita- The Lakshanas of Galagraha are Jwara (Fever), Aruchi (Anorexia), Mukh Strava (Salivationon). In Galagraha due to Hetusevana, Kapha Dosha vitiated, so to reduce kapha Dosha, Amrutprabha Gutika has been selected for the study. Most of the Dravya included in it has Kapha Vilayan, Chedan, Pachan, kaphaghna properties. Amrutprabha Gutika is mentioned in Yog Chintamani. No previous work has been done on Amrutprabha Gutika in Galagraha (Acute Pharyngitis) so it is selected for study. |