| CTRI Number |
CTRI/2023/05/052415 [Registered on: 09/05/2023] Trial Registered Prospectively |
| Last Modified On: |
04/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial on Naruvili Chooranam in the management of Iraippu Noi ( Bronchial Asthma) |
|
Scientific Title of Study
|
A PROSPECTIVE OPEN LABELLED ,SINGLE ARM,NON-RANDOMIZED SINGLE CENTRIC PHASE II CLINICAL EVALUATION OF NARUVILI CHOORANAM IN THE MANAGEMENT OF IRAIPPU NOI (BRONCHIAL ASTHMA) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R Kalaipriya |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College and Hospital Palayamkottai |
| Address |
Department of Pothu Maruthuvam,Government Siddha Medical College and Hospital,Palayamkottai,Tirunelveli 627002, Tamil Nadu
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9629818508 |
| Fax |
|
| Email |
kalaipriya319@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G Subashchandran MDs PhD |
| Designation |
Reader |
| Affiliation |
Government Siddha Medical College and Hospital,Palayamkottai |
| Address |
PG Department of Pothu Maruthuvam, OP NO 10 Government Siddha Medical College and Hospital,Palayamkottai,Tirunelveli 627002, Tamil Nadu
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443358271 |
| Fax |
|
| Email |
siddhadrgs21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr A Manoharan MDs PhD |
| Designation |
Professor and HOD |
| Affiliation |
Government Siddha Medical College and Hospital,Palayamkottai,Tirunelveli |
| Address |
PG Department of Pothu Maruthuvam, OP NO 10 Government Siddha Medical College and Hospital,Palayamkottai,Tirunelveli 627002, Tamil Nadu
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443886700 |
| Fax |
|
| Email |
drmanoharan25@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD facilities and Central Library of Government Siddha Medical college and Hospital |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical college and Hospital |
| Address |
Government Siddha Medical College and Hospital,Palayamkottai,Tirunelveli,Tamilnadu |
| 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 R Kalaipriya |
Government Siddha Medical College and Hospital |
PG Department of Pothu Maruthuvam,OP NO 10 ,Government Siddha Medical college and Hospital,Palayamkottai
Tirunelveli
TAMIL NADU |
9629818508
kalaipriya319@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Government Siddha Medical College and Hospital , Palayamkottai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J069||Acute upper respiratory infection,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NARUVILI CHOORANAM |
Dosage: 2.5g (bds)
Adjuvant: Hot water
Route: Oral
Frequency: twice a day
Duration:45 days |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.More than 30 and less than 60 years
2.Patient with the symptoms of dry cough,recurrent attacks of dyspnoea,hoarseness of voice,tightness of the chest,profuse sweating and wheezing
3.History of allergens,climatic changes
4.Patients who are willing to take radiological investigations & provide blood for lab investigations |
|
| ExclusionCriteria |
| Details |
1.Below 29 and above 60 years
2.Cardiac diseases
3.Chronic allergic bronchitis
4.Tuberculosis
4.COPD
5.Pregnancy and Lactating mothers
6.Status Asthmaticus
7.Systemic Hypertension
8.Autoimmune diseases
9.Drugs and chemicals
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
If during treatment or after treatment reduction of the following symptoms:
1.Tightness of the chest
2.Wheezing
3.Dyspnoea
4.Difficulty in both inspiration and Expiration |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Comparing the pre and post treatment of Peak Expiratory Flow rate
2.Comparing the following parameters before and after treatment.
a. Other clinical symptoms
2. Eosinophil (%) and ESR
3.Asthma Grade level
Grade 1:Intermittent
Grade 2: Mild Persistent
Grade 3: Moderate Persistent
Grade 4: Severe Persistent |
45 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
21/05/2023 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a Prospective Open Labelled Phase II non randomized clinical study to evaluate the therapeutic efficacy of NARUVILI CHOORANAM in the management of IRAIPPU NOI (BRONCHIAL ASTHMA) .The trial drug will be administered at the dose of 5 gram /twice a day (orally with hot water) 45 days in 40 patients.The trial period of 12 months will be carried out in Government Siddha Medical College and Hospital,Palayamkottai,Tirunelveli,Tamilnadu. The primary outcome will be the evaluation of therapeutic efficacy of the trial drug NARUVILI CHOORANAM . The secondary outcome will be the evaluation of Siddha Diagnostic Parameters,assessments of safety profile of trial drug,assessment of pharmacological and biochemical parameters of the trial drug. In case of any adverse events (AE) is noticed and it will be referred to pharmacovigilance department of SCRI. Further management of patients will be given in OPD facility. |