| CTRI Number |
CTRI/2024/08/072261 [Registered on: 09/08/2024] Trial Registered Prospectively |
| Last Modified On: |
23/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical Study to Assess the Efficacy of Kushmand Awaleha and Suvarna Prashana in Respiratory Allergic Disorders in Children |
|
Scientific Title of Study
|
Comparative Clinical Study to Assess the Efficacy of Kushmand Awaleha and Suvarna Prashana in Respiratory Allergic Disorders in Children |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kavyashree R |
| Designation |
Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Kaumarbhritya/ Balroga Faculty of Ayurveda IMS BHU Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9663154268 |
| Fax |
|
| Email |
pgdnc2020@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalpana Patni |
| Designation |
Assistant Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Kaumarbhritya/ Balroga Faculty of Ayurveda IMS BHU Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9456140578 |
| Fax |
|
| Email |
kalpana.patni@bhu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalpana Patni |
| Designation |
Assistant Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Kaumarbhritya/ Balroga Faculty of Ayurveda IMS BHU Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9456140578 |
| Fax |
|
| Email |
kalpana.patni@bhu.ac.in |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences Banaras Hindu University Varanasi India- 221005 |
|
|
Primary Sponsor
|
| Name |
Banaras Hindu University |
| Address |
Banaras Hindu University Varanasi India - 221005 |
| 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 Kalpana Patni |
SSL Hospital BHU Varanasi |
Department of Kaumarbhritya, Faculty of Ayurveda, Room No. 25, SSL Hospital BHU Varanasi, Uttarpradesh
Varanasi
UTTAR PRADESH |
9456140578
kalpana.patni79@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee IMS BHU Varanasi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J684||Chronic respiratory conditions dueto chemicals, gases, fumes and vapors. Ayurveda Condition: KASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Suvarna prashan along with Kushmand Avaleha, Reference: Kashyap Samhita sutrasthana lehadhyay, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 1(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Madhu ghrita), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kushmand Avaleha, Reference: Sharangdhar Samhita, Madhyam Khand, 8/1-3, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: cow milk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children for the present study will be screened out from the O.P.D. and I.P.D. of Kaumarbhritya Department of Bala Rog S.S.L. hospital BHU having 1. Cardinal features of respiratory allergy
2. History of at least 4 episodes in the last one year.
|
|
| ExclusionCriteria |
| Details |
 Pneumonia
 Tuberculosis
 Pleural effusion
 Emphysema
 Lung Abscess
 Bronchiactasis
 Pleurisy
 Nasal Polyposis
 Chronic debilitating disease
 Congenital anomalies
 patients with deviated nasal septum/ nasal polyps/ nasal growth/ adenoids
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of clinical symptoms – Rhinorrhoea, smell obliteration, sneezing, nasal obstruction, headache, change in voice, fever, dyspnea, itching (nasal/eye), wheezing, cough and sore throat, depending on the severity was done on four-point scale. • Pulmonary function test - Spirometry
• Haematological Investigation.
|
2 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • CARAT kids questionnaire to assess a child’s asthma and rhinitis control and thereby improvement in quality of life |
2 months |
|
|
Target Sample Size
|
Total Sample Size="23"
Sample Size from India="23"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
19/08/2024 |
| 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="0"
Days="0" |
|
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
|
In children Respiratory Allergic Disorders is one of the most common health issues which is dealed by Pediatrician. In modern medical system drugs like antitussives, bronchodilators, mucolytics and other drugs are used to treat the Respiratory Allergic Disorders. Inhaled steroids and bronchodilators play a key role in the management of Respiratory Allergic Disorders.However relapse or exacerbations are occurring even if they are used rationally. In Ayurveda there are many drugs which are used as Respiratory Allergic Disorders. One of the important drug preparations for the management of Respiratory Allergic Disorders in Kushmand Awaleha. The study is planned to use; Kushmand Awaleha and Suvranaprashan in the form of Leha in Respiratory Allergic Disorders in children. |