| CTRI Number |
CTRI/2016/10/007389 [Registered on: 20/10/2016] Trial Registered Retrospectively |
| Last Modified On: |
24/02/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to study the effect of Pankajakasthuri Breath Eazy Mishrit, in patients with cough, cold and breathing difficulties.
|
|
Scientific Title of Study
|
An open clinical trial for the assessment of efficacy of Pankajakasthuri Breath Eazy Mishrit in patients with 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 |
DrGSSreekumar |
| Designation |
Assistant Professor |
| Affiliation |
Pankajakasthuri Ayurveda Medical College and Post Graduate Centre |
| Address |
Pankajakasthuri Ayurveda Medical College and
Post Graduate Centre, Killy,
Kattakada, Thiruvananthapuram.
Pankajakasthuri Ayurveda Medical College and Post Graduate Centre, Killy, Kattakada, Thiruvananthapuram.
Thiruvananthapuram
KERALA
695572
India |
| Phone |
09486886362 |
| Fax |
04712293808 |
| Email |
gssreekumarnair@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrGSSreekumar |
| Designation |
Assistant Professor |
| Affiliation |
Pankajakasthuri Ayurveda Medical College and Post Graduate Centre |
| Address |
Pankajakasthuri Ayurveda Medical College and
Post Graduate Centre, Killy,
Kattakada, Thiruvananthapuram.
Pankajakasthuri Ayurveda Medical College and Post Graduate Centre, Killy, Kattakada, Thiruvananthapuram.
Thiruvananthapuram
KERALA
695572
India |
| Phone |
09486886362 |
| Fax |
04712293808 |
| Email |
gssreekumarnair@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSudhakumari |
| Designation |
Professor |
| Affiliation |
Pankajakasthuri Ayurveda Medical College and Post Graduate Centre |
| Address |
Pankajakasthuri Ayurveda Medical College and Post Graduate Centre, Killy, Kattakada, Thiruvananthapuram
Pankajakasthuri Ayurveda Medical College and Post Graduate Centre, Killy, Kattakada, Thiruvananthapuram.
Thiruvananthapuram
KERALA
695572
India |
| Phone |
08281782290 |
| Fax |
04712293808 |
| Email |
sudha14ayu@gmail.com |
|
|
Source of Monetary or Material Support
|
| PANKAJAKASTHURI AYURVEDA MEDICAL COLEGE AND POST GRADUATE CENTER |
|
|
Primary Sponsor
|
| Name |
Pankajakasthuri Ayurveda Medical College and Post Graduate Centre |
| Address |
Pankajakasthuri Ayurveda Medical College and Post Graduate Centre,KILLY KATTAKADA, THIRUVANANTHAPURAM |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| ARUNVISAKHS |
Chithramsu
kandala.p.o.
Thiruvananthapuram
695512 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrGSSREEKUMAR |
Pankajakasthuri Ayurveda Medical College and Post Graduate Centre |
Pankajakasthuri Ayurveda Medical College and Post Graduate Centre,KILLY KATTAKADA, THIRUVANANTHAPURAM
Thiruvananthapuram
KERALA |
09486886362
04712293808
gssreekumarnair@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PANKAJAKASTHURI RESEARCH CENTERIAEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: J454||Moderate persistent asthma, (2) ICD-10 Condition: J454||Moderate persistent asthma, The Patients with Bronchial Asthma visiting PANKAJAKASTHURI AYURVEDA MEDICAL COLLEGE OUT PATIENT DEPARATMENTS for consultation., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLLICABLE |
| Intervention |
PANKAJAKASTHURI BREATH EAZY MISHRIT |
DOSE : 20ML
ROUTE OF ADMINISTRATION : ORAL
FREQUENCY : THREE TIMES PER DAY TIME : AFTER FOOD
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Both sex with equal distributor with or without rhinitis.
3 Mild persistent cases of Asthma (as per WHO GINA Guideline) of duration more than 6 months.
Asthmatic meet reversibility criteria (15% improvement in FEVI after Beta – 2 agonist inhalation)
5
|
|
| ExclusionCriteria |
| Details |
Mild intermittent, moderate persistent, severe persistent to severe Asthma (As per WHO GINA guidlines of duration more than 6 months)
Dyspnoea due to other disease like Left ventricular failure, COPD (Chronic Bronchitis, Emphysema), Upper respiratory tract obstruction, Bronchiectasis, cases of tuberculosis, interstitial lung disease/occupational Lung disease, tropical pulmonary eosinophilia, Lofflers disease & Allergic Bronchopulmonary Aspergillosis etc.
Diabetes Mellitus and Hypertension.
Severe renal/Hepatic disease
HIV positive cases
Lung Cancer
Pregnant/lactating mother
Patient who need Salbutamol inhaler daily.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
More than 70% of participants had 100% releif Percentage calculation and assessment criteria based on scoring of grading by using the following parameters.
Frequency of swasa vega (Difficulty in respiration)
2Intensity and duration of attack
3Swasa krichrata (Dyspnoea)
4Ghurghurakam (Wheezing)
5Kaphashteevanam(Production of cough) |
SPECIFIC TIME FOR ASSESSING PRIMARY OUTCOME : 6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
More than 70% of participants had 100% releif Percentage calculation and assessment criteria based on scoring of grading by using the following parameters.
Frequency of swasa vega (Difficulty in respiration)
2Intensity and duration of attack
3Swasa krichrata (Dyspnoea)
4Ghurghurakam (Wheezing)
5Kaphashteevanam(Production of cough) |
SPECIFIC TIME FOR ASSESSING SECONDARY OUTCOME : 60 DAYS AND 90 DAYS |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
07/01/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Will be published once the CTRI registration is obtained. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a open clinical trial to asses the efficacy of PANKAJAKASTHURI BREATH EAZY MISHRIT in 60 patients with Bronchial Asthma visited the OPD of PANKAJAKASTHURI AYURVEDA MEDICAL COLLEGE HOSPITAL from 07.01.15 to 15.08.15. The severity of disease was graded under five scoring scales. The observation and calculations were made on the basis of relevant statistical methods. The primary outcome measure was done at the end of 2nd month and secondary outcome was measured at the end of 4th month, third at the end of 6th month. The observations on the basis of followup was also taken for statistical analysis. The statistical analysis by using paired t test produced the success rate by attaining P<0.001 shows the medicinal value of the product is highly significant in treating the disease- bronchial asthma with high percentage of improvements.
|