| CTRI Number |
CTRI/2022/12/048507 [Registered on: 26/12/2022] Trial Registered Prospectively |
| Last Modified On: |
23/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluation of comparative efficacy of Panchapallav Gargles versus Betadine Gargles in management of Vrunda(Pharyngitis) in children |
|
Scientific Title of Study
|
Evaluation of Comparative Efficacy of Panchpallav Gargles versus Betadine Gargles as in the management of Vrunda(Pharyngitis) in children- A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RIYA RAJENDRA RATHOR |
| Designation |
PG Scholar |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital, and Research centre, Salod, Wardha |
| Address |
Department of Kaumarabhritya, Mahatma Gandhi Ayurved College Hospital, and Research centre, Salod, Wardha
Mahatma Gandhi Ayurved College Hospital, and Research centre, Salod, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7499128427 |
| Fax |
|
| Email |
riyarathor140395@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RENU RATHI |
| Designation |
Head of Department Kaumarabhritya |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital, and Research centre, Salod, Wardha |
| Address |
Mahatma Gandhi Ayurved College Hospital, and Research centre, Salod, Wardha
Mahatma Gandhi Ayurved College Hospital, and Research centre, Salod, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9011058302 |
| Fax |
|
| Email |
rbr.226@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RIYA RAJENDRA RATHOR |
| Designation |
PG Scholar |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital, and Research centre, Salod, Wardha |
| Address |
Department of Kaumarabhritya, Mahatma Gandhi Ayurved College Hospital, and Research centre, Salod, Wardha
Mahatma Gandhi Ayurved College Hospital, and Research centre, Salod, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7499128427 |
| Fax |
|
| Email |
riyarathor140395@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved College Hospital and Research centre Salod (H) Wardha |
|
|
Primary Sponsor
|
| Name |
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH CENTRE |
| Address |
Mahatma Gandhi Ayurved College Hospital and Research centre Salod (H) Wardha |
| 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 Riya Rajendra Rathor |
Mahatma Gandhi Ayurved College Hospital, and Research centre, Salod, Wardha |
Departrment of Kaumarabhritya, Mahatma Gandhi Ayurved College Hospital and Research centre Salod (H) Wardha
Wardha
MAHARASHTRA |
7499128427
riyarathor140395@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J029||Acute pharyngitis, unspecified. Ayurveda Condition: VRUNDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Panchpallav Gargles, Reference: Bhaishajya Ratnavali, Route: Topical, Dosage Form: Kwatha/ Kashaya, Dose: 5(ml), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: water), Additional Information: 5 – 10 yr –
5ml/dose
(TDS) dilute
in 25 ml
water, hold it
for 1 min.
11 -14yr-
10ml/dose
(TDS) dilute
in 50 ml
water, hold it
for 1 min. | | 2 | Comparator Arm (Non Ayurveda) | | - | Betadine Gargles | Povidone- Iodine Germicide Gargle 2% w/v,
Route: Topical,
Dosage Form: 5ml dilute in 25ml water, hold it for 1 min,
Frequency: TDS,
Duration: 7 Days, |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed patients of Acute Mild Pharyngitis (Vrunda) between the age of 5 to 14 years presenting with clinical signs and symptoms less than 7 days, given Parent’s consent irrespective of gender, caste, religion & socio-economic background |
|
| ExclusionCriteria |
| Details |
- Known cases of Pneumonia, Bronchial Asthma, Bronchiectasis, Pleurisy, Tuberculosis, Malignancy and other systemic diseases with sore throat
- Congenital anomalies of Respiratory Tract
- Participants having Tobacco Addiction, Moderate and Severe grade fever
- Patient on any other medication |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in hoarseness of voice,soreness in throat (Ruk), Gala Shotha, Daha, Jwara, Suchividdhavatavedna, Kanthkandu,Ragatva(hyperemia)
|
7 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Increased oral intake |
14 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 |
|
Date of First Enrollment (India)
|
01/01/2023 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Pharyngitis is similar to, a condition Vrunda referenced by Charakacharya in Ayurvedic literature. The vitiation of Pittadosha and raktaprakopa, which settles in Mukha (Gala) pradesh as mentioned in Charaka Sutrasthan, is the primary cause of this ailment. 17 ailments in Kanthapradesh have been described by Acharya Sushruta. Pharyngitis is similar to Vrunda, a condition referenced by Charakacharya in Ayurvedic literature. So,Ashtang Hridaya, has mentioned the Kavala Chikitsa, which provides good relief in Mukhagat and Gala rogas, to get rid of such a severe sickness. Kavala not only soothes the throat (GalaPradesh), but it also precisely heals symptoms such as Shoth (inflammation), Shool (pain), Jwara(fever), and Aruchi (anorexia). Acharya Charakaand Kashyapa have not described Ekvrinda and Vrinda. Charaka description of the Galgraha on the basis of etiopathogenesis may be taken while Kashyapa description of the Galgraha & Kantashotha can be compared with Pharyngitis when evaluatedon the basis of clinical features.Tender cervical lymphadenopathy is also found in viral pharyngitis which can be denoted as Kanthavedana.
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