| CTRI Number |
CTRI/2023/12/060671 [Registered on: 22/12/2023] Trial Registered Prospectively |
| Last Modified On: |
21/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy
Screening |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of yoga in the Management of Bronchial Asthma
(Tamaka Shwasa) |
|
Scientific Title of Study
|
To Study the Effect of Yoga as an Add-On Therapy in the Management of Bronchial Asthma (Tamaka Shwasa) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chhaya Negi |
| Designation |
PhD Research Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Kayachikitsa
Faculty of Ayurveda
Institute of Medical Science
Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9627635602 |
| Fax |
|
| Email |
chhayanegi95@bhu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunanda R Pedhekar |
| Designation |
Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Kayachikitsa
Faculty of Ayurveda
Institute of Medical Science
Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9423241800 |
| Fax |
|
| Email |
drsrpedhekar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chhaya Negi |
| Designation |
PhD Research Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Kayachikitsa
Faculty of Ayurveda
Institute of Medical Science
Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9627635602 |
| Fax |
|
| Email |
chhayanegi95@bhu.ac.in |
|
|
Source of Monetary or Material Support
|
| Sir Sunderlal Hospital Faculty of Ayurveda Institute of Medical Sciences BHU Varanasi |
|
|
Primary Sponsor
|
| Name |
Department of Kayachikitsa Faculty of Ayurveda |
| Address |
Sir Sunderlal Hospital OPD NO-21 22 Indian Medicine Wing Institute of Medical
Sciences Banaras Hindu University Varanasi-221005 |
| 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 |
| Chhaya Negi |
Sir Sunderlal Hospital, IMS, BHU Varanasi |
Sir Sunderlal Hospital OPD NO-21 22 Indian Medicine Wing Institute of Medical
Sciences Banaras Hindu University Varanasi-221005
Varanasi
UTTAR PRADESH |
9627635602
chhayanegi95@bhu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Banaras Hindu University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J452||Mild intermittent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Drug |
Medicine Name: Modern Medicine
Step Therapy (standard dose)
As per GINA Guidelines
Route: Oral, Dosage Frequency: bd, Duration: 3 Months |
| Intervention |
Lifestyle |
Dinacarya: , Ritucarya: , Acara Rasayana:Other:
Procedure Reference: Hathayoga texts, other yogic texts & APMB, Procedure details: Yoga
intervention of 30 minutes (having selected Sookshma Vyayama,Asana, Pranayama,
Relaxation Techniques(meditation)
Medicine Name: Vasadi kwatha
Reference: Sarngadhara Samhita
MADHYAMA KHANDA, 2nd Chapter (Quatha Kalpana Adhyaya) & bhaisajya ratnavali ch. 16
Route: Oral Dosage
Form: Kwatha/Kashaya, Dose: 30
(ml), Frequency:bd, Duration: 3 months Pathya/Apathya:no,
Pathya:, Apathya: |
| Intervention |
Lifestyle |
Procedure Reference:
Hathayoga texts, other yogic texts & APMB Procedure
details: Designed Yoga protocol of 30 Minutes (having selected Sookshma Vyayama, Asana, Pranayama, Relaxation Techniques (Meditation)
Medicine Name: Modern Medicine
Step Therapy (standard dose)
As per GINA Guidelines
Route: Oral Dosage Frequency: bd, Duration: 3 Months
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group between 20 to 60 years.
2. Signs and Symptoms of bronchial asthma Breathlessness, coughing, wheezing, and feeling of chest tightness.
3. Patients willing and able to participate in Yoga as mentioned above intervention and give informed consent. |
|
| ExclusionCriteria |
| Details |
1. Age below 20 years and above 60 years.
2. Patients who are suffering from thrombosis, stroke, and other severe abnormalities.
3. Patients who are suffering from other complicated respiratory diseases, swine flu, chronic obstructive pulmonary diseases, etc.
4. Patient with Hemodynamic inabilities.
5. A patient with dementia severe who fail to understand and follow instruction for Yoga.
6. Patient with Neuromuscular condition due to which unable to perform Yoga. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The main sign and symptoms in the study are as follows
1. Regular cough especially at morning or night.
2. Allergies like sneezing, itching, blocked nose, running nose, congestion.
3. Production cough, chest tightening.
4. Excessive cough and mucus production.
5. Breathlessness
|
90 days study with follow up of
every 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of scoring of following scales
1. Spirometry
2. SPO2
3. Blood Pressure
4. Pulse Rate
5. SGRQ (St George’s Respiratory Questionnaire)
6. ACT (Asthma Control Test)
7. MMRC (Modified Medical Research Council)
|
90 days study with follow up of
every 30 days |
|
|
Target Sample Size
|
Total Sample Size="165"
Sample Size from India="165"
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 4 |
|
Date of First Enrollment (India)
|
02/01/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study design of an open-labeled randomized control clinical trial is planned for the research work.
About 165 patients attend the OPD and IPD of Sir Sunderlal Hospital, IMS, BHU, Varanasi. The cases will be screened
according to inclusion and exclusion criteria and those who will meet the criteria will be
registered for the present study. The registered cases will be randomly allocated into 2 trial
groups and 1 control group of equal sample size; each group has a sample size of 55. The Research Intervention will be given as per the protocols
developed for this purpose. These interventions will be given to the experimental groups, the total
duration of this study is 3 months and with 3 follow-ups at 30-day intervals.
Following are research groups. Experiment
Group (n=55) – Yoga Protocol with Ayurvedic Medicine.
Experiment
Group (n=55) – Yoga Protocol with Modern Medicine, Step Therapy
(standard dose) as Per GINA Guidelines. Control
Group (n=55) – Modern Medicine Step Therapy (standard dose) as per
GINA Guidelines. |