| CTRI Number |
CTRI/2018/01/011419 [Registered on: 18/01/2018] Trial Registered Prospectively |
| Last Modified On: |
17/01/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Agastyaharitaki Avleha and granules in Shwasa |
|
Scientific Title of Study
|
Pharmaceutical standardization of Agastyahareetaki Avaleha and Agastyahareetaki Granules and their comparative efficacy in the management of Tamaka Shwasa (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 |
Vasundhra Jaluthriya |
| Designation |
Research Scholar |
| Affiliation |
IPGT and RA |
| Address |
Second floor Department of Rasa Shastra and Bhaishjya Kalpna IPGT and RA Gujrat Ayurved University Jamnagar 361008 India
Jamnagar
GUJARAT
361008
India |
| Phone |
9116788795 |
| Fax |
|
| Email |
14vasu87@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B J Patgiri |
| Designation |
HOD Department of Rasa Shastra and Bhaishjya Kalpna |
| Affiliation |
IPGT and RA |
| Address |
Second floor Department of Rasa Shastra and Bhaishjya Kalpna IPGT and RA Gujrat Ayurved University Jamnagar 361008 India
Jamnagar
GUJARAT
361008
India |
| Phone |
9426947438 |
| Fax |
|
| Email |
Patgiri124@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vasundhra Jaluthriya |
| Designation |
Research Scholar |
| Affiliation |
IPGT and RA |
| Address |
Department of Rasa Shastra and Bhaishjya Kalpna IPGT and RA Gujrat Ayurved University Jamnagar India
Department of Rasa Shastra and Bhaishjya Kalpna IPGT and RA Gujrat Ayurved University Jamnagar India
GUJARAT
361008
India |
| Phone |
9116788795 |
| Fax |
|
| Email |
14vasu87@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute For Post Gradute Teaching and Research in Ayurveda Gujrat Ayurved University, jamnagar 361008 |
|
|
Primary Sponsor
|
| Name |
Institute For Post Gradute Teaching and Research in Ayurveda Gujrat Ayurved University |
| Address |
IPGT and RA Gujrat Ayurved University opposite city B Division Police station PN marg Jamnagar |
| 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 |
| Vasundhra jaluthriya |
IPGT AND RA |
Department of Rasa Shastra and Bhaishjya Kalpna IPGT and RA Gujrat Ayurved University Jamnagar India
Jamnagar
GUJARAT |
9116788795
14vasu87@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Insitutional ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
difficulty in breathing, cough, wheezing and chest tightness, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A |
Treated with Agatyaharitaki Avaleha 6 gram of the drug twice a daily for 60 days before meal |
| Comparator Agent |
Group B |
Treated with Agastyaharitaki granules 6 gram of the drug twice a daily for 60 days before meal |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Mild persistent cases of Bronchial Asthma with day time symptoms 3-6/week and nocturnal symptoms with 3-4/month.
2. Moderate persistence cases with daytime symptoms daily and nocturnal symptoms with one or more than one week but not more than 2 weeks. |
|
| ExclusionCriteria |
| Details |
1. Known patients of diabetes mellitus and uncontrolled HTN.
2. Dyspnoea resulting from cardiac origin, other lung pathologies (like-lower respiratory tract infection,Chronic obstructive pulmonary disease, Emphysema, upper respiratory tract obstruction, bronchiectasis,interstitial lung disease, occupational lung disease,tropical pulmonary eosinophilia,Tuberculosis, Pulmonary malignancy, chronic pluritis, plural effusion),anaemia.
3. Age above 60 years and below 16 years.
Pregnant and lactating mothers.
Patients suffering with other types of Shwasa,i.e. Maha, Urdha, ChhinnaShwasa will be excluded from the study.
4. Febrile patients on presentation or history of fever within past one week. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected that the trial drugs will exert a significant action over Tamaka Shwasa (Bronchial Asthma) |
2 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| significant relief in the sign and symptoms of tamaka shwasa (bronchial asthama) |
2 month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 1 |
|
Date of First Enrollment (India)
|
01/03/2018 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
No |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Bronchial asthma is characterized by difficulty in breathing, cough, wheezing and chest tightness. Paroxysm attack can last for days to months. which results in handicapped day and sleepless nights, thus disturbing the normal life style of the person. It is common and prevalent worldwide, equally affecting both sexes in adult but in children male female ratio is 2:1.Asthma, being a problem worldwide, has an estimated 330 million affected individuals and causing 2,50,000 deaths annually worldwide.1India has an estimated 15-20 million asthmatics.2Epidemiological data shows increased incidence and prevalence of Tamaka Shwasa imposing large burden to health services. Based on the similarities in aetio- pathogenesis and symptomatology, this condition can be compared with Tamaka Shwasa in Ayurveda.Ayurvedic system of Indian medicine is believed to promote positive health and maintain organic resistance against infection by establishing the body’s equilibrium and conditioning the body tissues. In recent years the plant material and herbal remedies derived from them represent a sustained proportion and has gained place in the health management throughout the globe. Conversion of formulations into various dosage forms so as to increase the palatability, shelf life etc. has gained great importance in market to meet the trend of the present era. In addition, the concept of standardization and quality control of final products is the major issue today regarding the Ayurvedic products. With the advancement of science, it is possible to provide a scientific basis and credibility to Ayurvedic drugs through which one can make efforts to meet the standards set for globalization. Different studies make clear that rasayana inAyurveda act simultaneously on different systems viz. the nervous - endocrine - immune systems. |