| CTRI Number |
CTRI/2024/05/067260 [Registered on: 14/05/2024] Trial Registered Prospectively |
| Last Modified On: |
09/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study 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
|
A Comparative clinical trial to evaluate the efficacy of Pippalyadikshar Gutika and Khadiradi Vati in management of 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 Pallavi Gangadhar Nimalwar |
| Designation |
M.S Scholar Shalakyatantra |
| Affiliation |
Mams Sumatibhai Shah Ayurved Mahavidyalaya,Hadapsar,Pune |
| Address |
OPD NO. 8 Department of Shalakyatantra, Sane Guruji Arogya Kendra,Malwadi Road Hadapsar,Pune
Pune
MAHARASHTRA
411028
INDIA
Pune
MAHARASHTRA
411028
India |
| Phone |
9146141870 |
| Fax |
|
| Email |
pallavinimalwar6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF DR MRS NILAKSHI PRADHAN |
| Designation |
H.O.D Shalakyatantra |
| Affiliation |
Mams Sumatibhai Shah Ayurved Mahavidyalaya,Hadapsar,Pune |
| Address |
OPD NO 8 Departmentt of Shalakyatantra, Sane Guruji Arogya Kendra,Malwadi Road Hadapsar, Pune
Pune
MAHARASHTRA
411028
INDIA
Pune
MAHARASHTRA
411028
India |
| Phone |
9423580963 |
| Fax |
|
| Email |
drnspradhan@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
PROF DR MRS NILAKSHI PRADHAN |
| Designation |
H.O.D Shalakyatantra |
| Affiliation |
Mams Sumatibhai Shah Ayurved Mahavidyalaya,Hadapsar,Pune |
| Address |
OPD NO 8 Department of Shalakyatantra, Sane Guruji Arogya Kendra,Malwadi Road Hadapsar,Pune
PUNE
MAHARASHTRA
411028
INDIA
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 road Hadapsar,Pune
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 Pallavi Gangadhar Nimalwar |
Mams Sumatibhai Shah Ayurved Mahavidyalaya,Hadapsar,Pune |
OPD NO. 8 Department of Shalakyatantra, Sane Guruji Arogya Kendra,Malwadi Road Hadapsar,Pune
PUNE
MAHARASHTRA
411028
INDIA
Pune
MAHARASHTRA |
9146141870
pallavinimalwar6@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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Khadiradi Vati, Reference: Ayurved Sarsamgraha, 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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pippalyadikshara Gutika, Reference: Bharat Bhaishjyaratnakar, 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 |
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, occupation.
2. All patients having signs and symptoms in Gala region as
a) Kanthashopha (Oedema in Oro-pharyngeal region) b) Kanthakandu(ItchinginOro-pharyngealregion)
c) Aaraktata (Posterior pharyngeal wall congestion)
religion,
3. All patients having body temperature ranging from 98.6 °F to 100 °F. |
|
| ExclusionCriteria |
| Details |
1. Patients having moderate to high grade fever, having body temperature above 100 °F
2. Patients having chronic conditions in pharynx like carcinoma in the pharynx / throat region/ oral cavity.
3. Patients having systemic illnesses like HTN,DM,HIV, Tuberculosis. |
|
|
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. |
Follow Up will be taken on 3rd and 7th day .Symptoms will be noted before and after treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Subject will get relief from Jwara (Low Grade Fever). |
18 Months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2024 |
| 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
|
There are various Galaroga’s explained by different Acharya’s among which is Galagraha is explained by Acharya Charaka.According to Acharya Charaka, kapha Dosha get aggravated due to different Hetusevana and it gets localised inside Gala region and produces local oedema.Acharya Kashyapa has given the symptoms of Galagraha like Jwara, Aruchi, Mukhastrava, and difficulty in breathing.Galaroga’s means Gala;throat region (pharynx and larynx).i.e. Galaroga’s occur at respiratory pathway therefore there is risk of obstruction in respiration. Hence they should be treated as soon they occur. As pharynx is common passage in both process of respiration and digestion and that’s why diseases of this throat region should be treated immediately to avoid further complication like pneumonia, sinusitis etc),
Pharyngitis (ICD Code 10-J02.9) is the inflammation of mucus membrane of oropharynx. It occurs due to varied etiological factors like viral, bacterial, fungal, and allergic factors such as mold, pollen, smoke, air, food, animal hairs, others. Discomfort in throat, some malaise and low-grade fever are seen. Pharynx in this region shows erythema.According to modern point of view antibiotics, analgesics, warm saline gargles are used for treating pharyngitis. But recurrent use of antibiotics, analgesics may cause resistance to medicines, hence the purpose of this study is to find permanent solution by Ayurvedic formulations.Vati means medicine in the tablet form, made up of combinations of various fine Ayurvedic Churna according to their properties.Vati Dharana means Vati kept in mouth for Dharana Karma, Vati is kept in mouth then it will mix with the saliva and ultimately it will help in reducing local symptoms like congestion, pain quickly.
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