| CTRI Number |
CTRI/2025/03/082008 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study the number of children effected with respiratory allergic disorders and effect of ayurvedic compound Brihat vasavleh and Shadbindu tail nasya reduce the allergic infection in children. Also to study the various factors responsible for the respiratory allergic disorder in children. |
|
Scientific Title of Study
|
COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF BRIHAT VASAVLEHA AND SHADBINDU TAIL NASYA IN THE MANAGEMENT OF PRANAVAHA SROTO DUSHTI W.S.R. OF 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 |
Dr Nazneen |
| Designation |
MD Scholar |
| Affiliation |
Madan Mohan Malviya Government Ayurved College Udaipur, |
| Address |
PG DEPARTMENT OF KAUMARBHRITYA Madan Mohan Malviya Government Ayurved College Rada ji choraha Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
8118805346 |
| Fax |
|
| Email |
drnaz696@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Ram Kumar |
| Designation |
Professor and Head of Department |
| Affiliation |
Madan Mohan Malviya Government Ayurved College Udaipur, |
| Address |
PG DEPARTMENT OF KAUMARBHRITYA Madan Mohan Malviya Government Ayurved College Rada ji choraha Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
8005857838 |
| Fax |
|
| Email |
drbhamuramkumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Ram Kumar |
| Designation |
Professor and Head Of Department |
| Affiliation |
Madan Mohan Malviya Government Ayurved College Udaipur |
| Address |
PG DEPARTMENT OF KAUMARBHRITYA Madan Mohan Malviya Government Ayurved College Rada ji choraha Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
8005857838 |
| Fax |
|
| Email |
drbhamuramkumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madan Mohan Malviya Government Ayurved College , Rada ji chouraha, District- Udaipur, Rajasthan, India pin code- 313001 |
|
|
Primary Sponsor
|
| Name |
Madan Mohan Malviya Government Ayurved College Udaipur |
| Address |
Madan Mohan Malviya Government Ayurved College Rada ji chouraha, District -Udaipur, Rajasthan, India Pin Code-313001 |
| Type of Sponsor |
Government medical college |
|
|
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 Nazneen |
MMMGA Hospital rada ji choraha and govt ayurved hospital motichohtta |
PG DEPARTMENT OF KAUMARBHRITYA madan mohan malviya government ayurved college, Rada ji choraha ,Udaipur
Udaipur
RAJASTHAN |
08118805346
drnaz696@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| 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:J069||Acute upper respiratory infection,unspecified. Ayurveda Condition: PRANAVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Brihat Vasavleh, Reference: bhaishajya ratnavali, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 88(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 56 Days, anupAna/sahapAna: Yes(details: lukewarm water), Additional Information: Brihat Vasavleh along with shadbindu nasya (pratimarsh nasya) will given 56 days
dose- 6 bindu
route-nasal | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: honey syrup, Reference: charak, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 56 Days, anupAna/sahapAna: No, Additional Information: placebo (honey syrup) along with shadbindu tail nasya |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Children whose parents are willing to give consent/assent for clinical trial.
Children having cardinal features of respiratory allergy.
Children aged between 06 years to 14 years of either sex.
Children with a history of three or more episode within the past year. |
|
| ExclusionCriteria |
| Details |
Children cases of respiratory allergies that are severe and complicated. Children aged below 06 years and above 14 years of either sex.
Children suffering from major systemic illness necessitating long-term treatment.
Children with evidence of malignancy, genetic or congenital anomaly.
Children diagnosed with Tuberculosis, Plural effusion, Emphysema, Lung abscess,
Bronchiectasis, Pleurisy, Nasal polyps etc.
H/o hypersensitivity to any of the trial drug or their ingredient. . |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to check the effectiveness and efficacy of the drug and procedure in Respiratory Allergic Disorders |
56 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare both the drugs |
56 days |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
17/03/2025 |
| 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="0"
Months="9"
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
|
This study is conducted on upper respiratory tract infections on 60 cases through brihat vasavleh and shadbindu tail nasya . To conduct the study two groups will be there group A - brihat vasavleh and shadbindu tail nasya group B- placebo and shadbindu tail nasya
|