| CTRI Number |
CTRI/2018/01/011184 [Registered on: 08/01/2018] Trial Registered Prospectively |
| Last Modified On: |
04/01/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A trial to check the effect of Capsule and syrup Shwasi in the management of Shwas Roga w.s.r. to Bronchial Asthma. |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy and safety of ayurvedic formulations (Capsule and syrup Shwasi) in the management of Tamak Shwas w.s.r. to 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 |
Prof B L Mehra |
| Designation |
prof and head department of kayachikitsa |
| Affiliation |
rajiv gandhi govt post graduate ayurvedic college and hoapital Paprola |
| Address |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418017615 |
| Fax |
|
| Email |
mehra_bl@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof B L Mehra |
| Designation |
prof and head department of kayachikitsa |
| Affiliation |
rajiv gandhi govt post graduate ayurvedic college and hoapital Paprola |
| Address |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418017615 |
| Fax |
|
| Email |
mehra_bl@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof B L Mehra |
| Designation |
prof and head department of kayachikitsa |
| Affiliation |
rajiv gandhi govt post graduate ayurvedic college and hoapital Paprola |
| Address |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola
Adarsh colony Panthehar Teh Baijnath Distt Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418017615 |
| Fax |
|
| Email |
mehra_bl@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Dhanwantri Herbals Amritsar |
|
|
Primary Sponsor
|
| Name |
Shree Dhanwantri Herbals Amritsar |
| Address |
Shree Dhanwantri Herbals Amritsar |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 |
| Prof B L Mehra |
Paprola Ayurvedic Hospital |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola Department of Kayachikitsa Room No 315 Hospital Building
Kangra
HIMACHAL PRADESH |
9418017615
mehra_bl@rediffmail.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 |
Patients with Episodic Bronchial Asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cap Shwasi and Syrup Shwasi |
group 1- 2 Capsule(500mg) TID with water for 30 days
group2- 10 ml TID + 2 Capsules(500mg) TID with water for 30 days |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients willing for trial.
2. Age between 20 -60 years of either sex.
3. Patients presenting with clinical features of Tamak Shwas/Bronchial Asthma with impaired PFT.
|
|
| ExclusionCriteria |
| Details |
1. Patients not willing for the trial or not ready to give informed consent.
2. Patients of age < 20 and above 60 years
3. Patients with Uncontrolled Hypertension and
Diabetes mellitus with complications.
4. Patients having malignancy, chronic cardiac illness, hepatic disorders, renal disorders, tuberculosis and other comorbid diseases.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| awaited |
after every 15 days till completion of the trial |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| awaited |
every 15 days after initiating the therapy till completion of the trial |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2 |
|
Date of First Enrollment (India)
|
19/01/2018 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Respiration or breathing in and out
is the evidence feature of life. The prevalence of respiratory disorders is
increasing due to increasing pollution, overcrowding and poor hygiene. Tamak
Shawas is a variety of Shwas roga associated with difficulty in breathing.
Movement of air through the Pranvaha Sarotas is hampered in this
disease resulting in the cry of the organ heading towards complete failure for
want of air. Tamak Shwas well known for its episodic and chronic
course which comes under the life threatening diseases. It is analogous to
Bronchial Asthma in Modern system of medicine due to similarity in symptoms,
pathogenesis, onset, causes and precipitating factors. Tamak shwas
is characterized by paroxysmal attacks of breathlessness, cough, coryza and chest
tightness, rapid respiration distress due to inability to expectorate and
prolonged expiration.
The trial formulation Cap and Syrup
Shwasi is a partial organic herbomineral preparation taken for clinical trial. |