| CTRI Number |
CTRI/2013/12/004253 [Registered on: 27/12/2013] Trial Registered Retrospectively |
| Last Modified On: |
19/12/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
CLINICAL RESEARCH ON SIDDHA MEDICINE IN IYA ERAIPPU NOI(BRONCHIAL ASTHMA) |
|
Scientific Title of Study
|
EVALUATION OF SAFETY AND EFFICACY OF A POLY HERBAL FORMULATION ADATHODAI CHOORANAM IN IYA ERAIPPU NOI(BRONCHIAL ASTHMA) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIS/PPHD/11/0104 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DRHVETHA MERLIN KUMARI |
| Designation |
LECTURER |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
NATIONAL INSTITUTE OF SIDDHA,TAMBARAM SANATORIUM,
CHENNAI
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9894782366 |
| Fax |
044-22381314 |
| Email |
dr.vetha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF DR K MANICKAVASAKAM |
| Designation |
DIRECTOR |
| Affiliation |
NATIONAL INSTITUTE OF SIDDHA |
| Address |
NATIONAL INSTITUTE OF SIDDHA,TAMBARAM SANATORIUM,
CHENNAI
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9444979034 |
| Fax |
044-22381314 |
| Email |
dr.kmvm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR THOMAS M WALTER |
| Designation |
LECTURER(Selection grade) |
| Affiliation |
GOVT.SIDDHA MEDICAL COLLEGE HOSPITAL |
| Address |
DEPARTMENT OF GUNAPADAM(PHARMACOLOGY)
GOVT.SIDDHA MEDICAL COLLEGE HOSPITAL, PALAYAMKOTTAI
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443378798 |
| Fax |
0462-2572736 |
| Email |
dr.thomaswalter@gmail.com |
|
|
Source of Monetary or Material Support
|
| AYOTHIDOSS PANDITHAR HOSPITAL
NATIONAL INSTITUTE OF SIDDHA
TAMBARAM SANATORIUM
CHENNAI
TAMILNADU
INDIA |
|
|
Primary Sponsor
|
| Name |
AYOTHIDOSS PANDITHAR HOSPITAL |
| Address |
AYOTHIDOSS PANDITHAR HOSPITAL,NATIONAL INSTITUTE OF SIDDHA, TAMBARAM SANATORIUM,CHENNAI,TAMIL NADU,INDIA |
| 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 H VETHA MERLIN KUMARI |
AYOTHIDOSS PANDITHAR HOSPITAL |
OPD.NO:1
DEPT.OF MARUTHUVAM
AYOTHIDOSS PANDITHAR HOSPITAL,
NATIONAL INSTITUTE OF SIDDHA,TAMBARAM SANATORIUM,
Kancheepuram
TAMIL NADU |
9894782366
044-22381314
dr.vetha@gmail.com |
|
|
Details of Ethics Committee
|
| 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 |
IYA ERAIPPU NOI(BRONCHIAL ASTHMA), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ADATHODAI CHOORANAM |
1.5 gm of Adathodai chooranam will be administered along with milk twice a day orally for a period of 30 days. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who are having classical symptoms of Bronchial Asthma that difficulty in breathing, Tightness of Chest, Wheezing, Dry (or) Productive Cough,
2.Only new patients will be included.
3.Aged between 15 to 60 years of both sexes.
4.Willing to give blood specimen, sputum, Radiological Investigation and Willing to be admitted in the hospital (or) attend the OPD once a week for 3 weeks.
5.Patients who are willing to estimate volume of air forcibly expired after a deep inspiration by using peak flow meter
|
|
| ExclusionCriteria |
| Details |
1.Pregnancy and Lactation period.
2.Significant Systemic illness including Cardiac Diseases, Renal Diseases, Hypertension.
3.Patients with only nasal block or rhinorrhoea.
4.Other respiratory Diseases such as Tuberculosis, Pneumonia, COPD,Bronchiectasis, cystic fibroisis,
5.Endocrine Disorders like Hypo & Hyper Thyroidism, Diabetes Mellitus
6.Status Asthmaticus.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
PEEK EXPIRATORY FLOW MEASUREMENT
Outcome
Good response
Step4 Step1/Step2/Normal
Step3 Step1/Step2/Normal
Moderate response
Step4 to Step3
no Significant
Poor response
|
PRE STUDY SCREENING AND AFTER 30 DAYS OF TREATMENT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Eosinophils and ESR,
AEC, Serum IgE level
Pulmonary function tests,
X-ray Chest
|
PRE STUDY SCREENING AND AFTER 30 DAYS OF TREATMENT |
|
|
Target Sample Size
|
Total Sample Size="125"
Sample Size from India="125"
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)
|
15/12/2013 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is a single, non-randomized, open-label trial to determine the efficacy and safety of ADATHODAI CHOORANAM in patients with IYA ERAIPPU NOI (BRONCHIAL ASTHMA). The trial drug Adathodai Chooranam is a herbal formulation taken from the classical Siddha text Book ‘Sigitcha Rathna Deepam Enum Vaidhya Nool’ Page No.118 & 119 which is a approved text Book of Drug and Cosmetics Act 1940.In this trial 125 Bronchial asthma patients will be recruited and the trial drug will be administered 1.5 gm twice a day along with milk for a period of 30 days. During this trial period all the study related data will be recorded and documented in a separate trial master file for each patients.During the trial period if any AE/SAE/SUSAR will be noticed and referred to pharmacovigilance dept.in NIS and further management will also be given in NIS OPD/IPD. The entire trial will be monitored by the research monitoring committee OF NIS. During this trial all the safety and efficacy parameters will be recorded in the CRF. After completion of the trial all the study related data will be analysed statistically .The out come of this trial will be published in Indian Journal of Medical Research.
|