| CTRI Number |
CTRI/2025/06/088752 [Registered on: 12/06/2025] Trial Registered Prospectively |
| Last Modified On: |
11/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy of bilvadi gutika in allergic conditions |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of bilvadi gutika in blood eosinophilia |
| 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 Raghavendra Swamy P |
| Designation |
Post graduation student |
| Affiliation |
Alvas ayurveda medical collage and hospital |
| Address |
Alvas ayurveda medical college and hospital, vidyagiri, moodubidre, dakshina kannada, Karnataka 574227
Alvas ayurveda medical college and hospital, vidyagiri, moodubidre, dakshina kannada, Karnataka 574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
6362020667 |
| Fax |
|
| Email |
swamyrockstar.007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SUMANTH SHENOY H |
| Designation |
Professor and HOD |
| Affiliation |
Alvas ayurveda medical hospital |
| Address |
Alvas ayurveda medical college and hospital, vidyagiri, moodubidre, dakshina kannada, Karnataka 574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
7353162353 |
| Fax |
|
| Email |
shenoysumanth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SUMANTH SHENOY H |
| Designation |
Professor and HOD |
| Affiliation |
Alvas ayurveda medical hospital |
| Address |
Alvas ayurveda medical college and hospital, vidyagiri, moodubidre, dakshina kannada, Karnataka 574227
Alvas ayurveda medical college and hospital, vidyagiri, moodubidre, dakshina kannada, Karnataka 574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
7353162353 |
| Fax |
|
| Email |
shenoysumanth@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Raghavendra Swamy P |
| Address |
Alvas Ayurveda Medical College and Hospital, Moodubidire Dakshina kannada- 574227, karnataka |
| Type of Sponsor |
Other [self ] |
|
|
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 Raghavendra Swamy P |
Alvas ayurveda medical college and hospital |
Alvas Ayurveda Medical College and Hospital, Moodubidire dakshina kannada, karnataka. 574227. india
Dakshina Kannada
KARNATAKA |
6362020667
swamyrockstar.007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Alvas ayurveda medical college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D899||Disorder involving the immune mechanism, unspecified. Ayurveda Condition: VISHA-ANNAPANAGANDHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bilvadi gutika , Reference: ashtanga hridaya uttara sthana 36th chapter, shloka number 84 - 85, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -hot water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patient suffering from allergic asthma, allergic cough and allergic skin manifestation since 1 year. diagnosed cases of allergy with not more than 1 year. raised total and absolute eosinophil counts. patient with who have taken anthelminthic drugs at least 3-4 months before. |
|
| ExclusionCriteria |
| Details |
patient suffering from psychological disorders, pregnant and lactating women. patient suffering from other systemic diseases or other skin diseases that interfere in prognosis and treatment of disease. patient suffering from fatal diseases like carcinoma of lungs and immunocompromised cases. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce in absolute eosinophil counts |
Reduce in absolute eosinophil counts |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduction in subjective parameter. |
reduction in symptoms & signs |
|
|
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 3 |
|
Date of First Enrollment (India)
|
23/06/2025 |
| 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="4"
Days="0" |
|
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 clinical study is about intervention of an ayurvedic formulation called bilvadi gutika in allergic conditions as per the ayurvedic classical reference in order to check the reduce in absolute eosinophil count in the cases of blood eosinophilia. the aim is to study the effect of bilvadi gutika in blood eosinophilia. it is a single arm clinical study with minimum of 30 subjects fulfilling the diagnostic and inclusion criteria, such as the subject with a history of any allergy since 1 year, diagnosis cases of allergy, raised total eosinophil count and raised absolute eosinophil count. subjects will be included between 16 to 60 years of age irrespective of gender. the subject will be administered bilvadi gutika in the dosage of 500mg 2 tablets thrice daily with hot water for 4 weeks. post trial follow up period is 4 weeks. total duration of study is 8 weeks. the observation will be done initially on 1st day before the treatment after 28th day and after 56th day. the effect of treatment will be assessed on the basis of gradation for both subjective and objective parameter before and after the treatment. |