| CTRI Number |
CTRI/2021/02/031231 [Registered on: 11/02/2021] Trial Registered Prospectively |
| Last Modified On: |
01/06/2022 |
| 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 KUPPAIMENI CHOORANAM in the management of IRAIPPU IRUMAL(BRONCHIAL ASTHMA) |
|
Scientific Title of Study
|
A Prospective Open labelled non randomized phase II clinical study on KUPPAIMENI CHOORANAM in the management of IRAIPPU IRUMAL(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 |
Kalaiselvi Balakrishnan |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
PG Department of Pothu Maruthuvam,OP no 10,
Government Siddha Medical College and Hospital, Palayamkottai,Thirunelveli-627002, Tamilnadu
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
7907869866 |
| Fax |
|
| Email |
kalaiselvibalakrishnan08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ProfDr A Manoharan MDsPhD |
| Designation |
Professor and HOD |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
PG Department of Pothu Maruthuvam,OP no 10,
Government Siddha Medical College and Hospital, Palayamkottai,Thirunelveli-627002, Tamilnadu
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443886700 |
| Fax |
|
| Email |
drmanoharan25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ProfDr A Manoharan MDsPhD |
| Designation |
Professor and HOD |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
PG Department of Pothu Maruthuvam,OP no 10,
Government Siddha Medical College and Hospital, Palayamkottai,Thirunelveli-627002, Tamilnadu
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 |
| Kalaiselvi Balakrishnan |
Government Siddha Medical College and Hospital |
PG Department of Pothu Maruthuvam,OP no 10,
Government Siddha Medical College and Hospital, Palayamkottai,Tirunelveli-627002, Tamilnadu
Tirunelveli
TAMIL NADU |
7907869866
kalaiselvibalakrishnan08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J459||Other and unspecified asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
KUPPAIMENI CHOORANAM |
30mg/Kg/BW/Twice a day(orally) with Hot water |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient with the symptoms of dry cough, recurrent attacks of dyspnoea,hoarseness of voice,tightness of chest,profuse sweating and wheezing
2.History of allergens, climatic changes
3.Patients who are willing to take radiological investigation and provide blood for lab investigation. |
|
| ExclusionCriteria |
| Details |
1.Cardiac Diseases
2.Chronic allergic bronchitis
3.Tuberculosis
4.COPD
5.Pregnancy and Lactating mother
6.Restrictive airway disease
7.Status Asthmaticus
8.Systemic Hypertension
9.Autoimmune Diseases
10.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.Dry cough
2.Recurrent attacks of dyspnoea
3.Hoarseness of voice
4.Tightness of chest
5.Profuse sweating
6.Wheezing |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the pharmacological activities
2.Study about the prevalence of Iraippu Irumal in relation between diet and life styles
3.To determine about Antimicrobial activities in different solvents
4.To find out primary phytochemical analysis in trial drug
5.To evaluate spirometric changes in Iraippu Irumal
6.To evaluate safety profile for acute and subacute toxicity
7.To perform bio chemical analysis |
45 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
02/04/2021 |
| Date of Study Completion (India) |
24/05/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study is a Prospective Open labelled phase II non randomized clinical study to evaluate the therapeutic efficacy of KUPPAIMENI CHOORANAM in the management of IRAIPPU IRUMAL (BRONCHIAL ASTHMA). The trial drug will be administered at the dose of 30mg/Kg/BW /twice a day(orally) A/F 45 days along with Hot water as adjuvant in 60 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 evaluation of therapeutic efficacy of trial drug KUPPAIMENI CHOORANAM. The secondary outcome will be the evaluations of Siddha diagnostic parameters, assessment of safety profile of trial drug,assessment of pharmacological and biochemical parameters of 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. |