| CTRI Number |
CTRI/2017/01/007635 [Registered on: 06/01/2017] Trial Registered Prospectively |
| Last Modified On: |
03/01/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Standardization Of Ashwakanchuki Rasa And Its Clinical Efficacy In The Management Of Tamaka Shwasa(Bronchial Asthma) |
|
Scientific Title of Study
|
Scientific evaluation of Ashwakachuki Rasa with special reference to shwasa roga (Bronchial Asthama ) (pharmaceutical, analytical and clinical study) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
dr Vidhi M Shukla |
| Designation |
B.A.M.S. , M.D. scholar |
| Affiliation |
J.S.Ayurveda mahavidhyalaya |
| Address |
Post graduate department of rasashastra and bhaishajya kalpana department, J.S.Ayurved College,
College Rd, Nalanda Nagar, Yogiraj Society, Nadiad, Gujarat
Kheda
GUJARAT
387001
India |
| Phone |
02682520724 |
| Fax |
0268-2520646 |
| Email |
vidhishukla16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradip Vaishnav |
| Designation |
Principal |
| Affiliation |
J.S.Ayurveda college, Nadiad, 387001 |
| Address |
Post graduate department of rasashastra and bhaishajya kalpana department, J.S.Ayurved College,
College Rd, Nalanda Nagar, Yogiraj Society, Nadiad, Gujarat
Kheda
GUJARAT
387001
India |
| Phone |
02682520724 |
| Fax |
0268-2520646 |
| Email |
ayurvednadiad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
dr Vidhi M Shukla |
| Designation |
B.A.M.S. , M.D. scholar |
| Affiliation |
J.S.Ayurveda mahavidhyalaya |
| Address |
Post graduate department of rasashastra and bhaishajya kalpana department, J.S.Ayurved College,
College Rd, Nalanda Nagar, Yogiraj Society, Nadiad, Gujarat
Kheda
GUJARAT
387001
India |
| Phone |
02682520724 |
| Fax |
0268-2520646 |
| Email |
vidhishukla16@gmail.com |
|
|
Source of Monetary or Material Support
|
| P.D.Patel Ayurveda hospital |
|
|
Primary Sponsor
|
| Name |
JS Ayurveda Mahavidhyalaya |
| Address |
J.S. Ayurveda Mahavidhyalaya, college road, nadiad |
| 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 |
| vidhi M Shukla |
J.S.Ayurveda college |
Kayachikitsa and Panchkarma Department,J.S.Ayurveda college,
College Rd, Nalanda Nagar, Yogiraj Society, Nadiad, Gujarat 387001
Kheda
GUJARAT |
9428803009
vidhishukla16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Bronchial Asthama, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ashwakanchuki Rasa with additional Ardraka swarasa bhavna |
125 BD with honey for 28 days |
| Intervention |
Ashwakanchuki Rasa with bhringraja swarasa Bhavna |
125 mg BD with Ardraka Swarasa for 28 days |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Mild persistent case of Asthma (as per WHO gina guidelines) with duration of more than 6 months.
|
|
| ExclusionCriteria |
| Details |
Patient having pneumonia, lung collapse, pneumothorax, parenchymal lung disease, lower respiratory tract infection, pleural effusion, lung cancer, lung abscess and other complicated condition.
• HIV positive case |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| the patients will be followed for 4 week. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patients will be reviewed after 15 days of completion of the treatment. |
15 days |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
23/01/2017 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Patients having classical symptoms of Tamaka shwasa ( bronchial asthama )will be enrolled and administered with AKR-001 & AKR-002 in the dose of 125 mg BD with Ardraka swarasa and honey respectively for 4 weeks. Necessary investigation will be done before and after the treatment. |