| CTRI Number |
CTRI/2011/12/002204 [Registered on: 05/12/2011] Trial Registered Retrospectively |
| Last Modified On: |
10/10/2011 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Vyaghrihareetaki Avaleha and Granules on Tamaka Shwasa (Bronchial Asthma) |
|
Scientific Title of Study
|
Pharmaceutical Standardization of Vyaghrihareetaki Avaleha and Granules and their effect on 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 |
Roshy Joseph C |
| Designation |
Ph.D. Scholar |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
Department of Rasa shastra and Bhaishajya kalpana
Institute for Post Graduate Teaching and Research in Ayurveda
Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9624775660 |
| Fax |
|
| Email |
himaroshy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Biswajyoti Patgiri |
| Designation |
Reader |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
Department of Rasa shastra and Bhaishajya kalpana
Institute for Post Graduate Teaching and Research in Ayurveda
Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9426947438 |
| Fax |
|
| Email |
patgiri06@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Roshy Joseph C |
| Designation |
Ph.D. Scholar |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
Department of Rasa shastra and Bhaishajya kalpana
Institute for Post Graduate Teaching and Research in Ayurveda
Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9624775660 |
| Fax |
|
| Email |
himaroshy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Post Graduate Teaching and Research in Ayurveda
Gujarat Ayurved University
Jamnagar 361008 |
|
|
Primary Sponsor
|
| Name |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
Gujarat Ayurved University
Jamnagar - 361008
Gujarat |
| 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 |
| Roshy Joseph C |
Department of Rasa shastra and Bhaishajya kalpana |
Institute for Post Graduate Teaching and Research in ayurveda
Gujarat Ayurved University
jamnagar 361008
Jamnagar
GUJARAT |
9624775660
himaroshy@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 |
Tamaka shwasa
Bronchial asthma , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Vyaghrihareetaki avaleha (Jaggery based) |
10 gms twice daily for 4 weeks |
| Comparator Agent |
Vyaghrihareetaki avaleha (Sugar candy based) |
10 gms twice daily for 4 weeks |
| Comparator Agent |
Vyaghrihareetaki granules |
10 gms twice daily for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having signs and symptoms of Tamaka Shwasa as described in Ayurvedic classics.
2. Mild persistent cases of Asthma (as per WHO GINA Guideline) of duration more than 6 months.
3. Symptoms/exacerbation (Wheeze, cough and breathlessness) more than once a week but less than once a day in frequency
|
|
| ExclusionCriteria |
| Details |
1. Age more than 60 years and below 16 years.
2. Mild intermittent, Moderated persistent, severe persistent to severe Asthma.
3. Dyspnoea resulting from other diseases 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 & allergic bronchopulmonary aspergillosis etc.
4. Patients having anaemia, pneumonia, tuberculosis, lung cancer, lung abscess and other such complicated conditions.
5. Patients having diabetes, hypertension, Chronic and Acute renal failure etc. conditions in which urination is markedly diminished or excessive were excluded.
6. HIV positive cases.
7. Pregnant/lactating mother.
8. Patients having classical symptoms of Maha, Urdha, Chinna and Kshudra Shwasa.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Changes in the cardinal symptoms of Tamaka shwasa.
2. Changes in ACQ and ACT score and PEFR. |
0, 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Respiratory rate and Breath holding time |
0, 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/07/2010 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is an Open, Randomized, Controlled, Clinical study to evaluate the efficacy of Group A - Vyaghrihareetaki avaleha (jaggery based), Group B - Vyaghrihareetaki avaleha (sugar candy based), Group C - Vyaghrihareetaki granules (sugar candy based) in the management of Tamaka shwasa (Bronchial asthma). The primary outcome measures are Changes in signs and symptoms of Tamala shwasa, ACQ, ACT score, Respiratory rate, Breath holding time, PEFR changes before treatment and after 4 weeks. |