| CTRI Number |
CTRI/2022/04/041764 [Registered on: 11/04/2022] Trial Registered Prospectively |
| Last Modified On: |
08/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Management of Shwasa (Bronchial Asthma) with the help of Ayurved and Pranayama |
|
Scientific Title of Study
|
Evaluation of comparative efficacy of Anuloma Viloma Pranayama versus Nadishodhana Pranayama as an add on therapy with standard therapy in Shwas (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 |
Dr Premkumar Badwaik |
| Designation |
Professor & HOD PhD Scholar |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Wardha Maharashtra |
| Address |
Department of Swasthavritta
First floor, Room No.3
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Wardha Maharashtra
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Wardha Maharashtra
IPD and OPD Department of Panchakarma
Wardha
MAHARASHTRA
442001
India |
| Phone |
9822253328 |
| Fax |
|
| Email |
premkumar.badwaik@dmimsu.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinod Ade |
| Designation |
Professor Department of Panchakarma |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Wardha Maharashtra |
| Address |
Department of Panchakarma MGACH and RC Salod (H) Wardha
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Wardha Maharashtra
IPD and OPD Department of Panchakarma MGACH and RC Salod (H) Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9689365368 |
| Fax |
|
| Email |
vinod.ade@dmimsu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Premkumar Badwaik |
| Designation |
Professor & HOD PhD Scholar |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Wardha Maharashtra |
| Address |
Department of Swasthavritta
First Floor, Room No.3
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Wardha Maharashtra
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Wardha Maharashtra
IPD and OPD Department of Panchakarma MGACH and RC Salod (H) Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9822253328 |
| Fax |
|
| Email |
premkumar.badwaik@dmimsu.edu.in |
|
|
Source of Monetary or Material Support
|
| Dattatraya Rasashala of Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Wardha Maharashtra |
|
|
Primary Sponsor
|
| Name |
Dr Premkumar Badwaik |
| Address |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Wardha Maharashtra |
| Type of Sponsor |
Other [Self ] |
|
|
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 |
| Dr Premkumar Badwaik |
MGACH and RC Salod (H) |
OPD and IPD Department of Panchakarma and Kayachikitsa Wardha Maharashtra
Wardha
MAHARASHTRA |
9822253328
premkumar.badwaik@dmimsu.edu.in |
|
|
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 |
(1) ICD-10 Condition:J96-J99||Other diseases of the respiratory system. Ayurveda Condition: SVASAH, (2) ICD-10 Condition:J984||Other disorders of lung. Ayurveda Condition: SVASAH, (3) ICD-10 Condition:J99||Respiratory disorders in diseasesclassified elsewhere. Ayurveda Condition: SVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | Anuloma Viloma Pranayama | (Procedure Reference: Jain MK Joshi N Assessment of the effect of Anulom Vilom pranayama as an adjuvant therapy in asthma patients Int J Med Sci Educ Jan February 2020 7 (1)79 to 83, Procedure details: The patient must sit up straight seal the right nostril with the right thumb and inhale slowly for 2 seconds via the opposite nostril Exhale for 4 seconds after closing the left nostril with the ring finger and removing the thumb from the right nostril Inhale via the right nostril once again and go over the system The workout was done for 10 minutes once a day They were instructed to train for 10 minutes every day for around 6 months)
(1) Medicine Name: Kantakari Ghana Vati, Reference: Sharangdhar Samhita Madhyam Khand Adhyaya 8 -1, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 6 Months | | 2 | Intervention Arm | Procedure | - | Nadishodhana Pranayama | (Procedure Reference: Bhargava R Gogate MG and Mascarenhas JF Autonomic responses to breath holding and its variations following pranayama Indian J Physiol Pharmacol 32 257to 264 1988., Procedure details: 1 Bend the index and middle fingers of the right hand adjacent to the palm The right nostril was closed with the thumb while the left nostril was closed with the fourth and fifth fingers 2 Press the fourth and fifth fingertips against the left nostril to close it and the right thumb against the ala at the end of the nostril to close it 3 Begin the workout in the Sukhasana position having a calm demeanor and focused attention as shown below 3.1 Exhale slowly and deeply without closing your nostri)
(1) Medicine Name: Kantakari Ghana Vati, Reference: Sharangdhar Samhita Madhyam Khand Adhyaya 8-1, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 6 Months |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
i) Patients suffering from mild Shwasa (Bronchial asthma)
ii) Mild hypertension
iii) Chronic patients of Shwasa but not on bronchodilators and steroids (Bronchial asthma)
iv)Patients who are dedicated to perform pranayama as educated by yoga teacher on a regular basis.
|
|
| ExclusionCriteria |
| Details |
i)Suffering from comorbidities
ii) Congestive Cardiac failure
iii) Tropical pulmonary eosinophilia
iv) Old & active Pulmonary Tuberculosis
v) COPD
vi) Bronchiectasis
vii) Spontaneous pneumothorax
viii) Drug dependent cases
ix) Pregnant women
x) Smokers and alcoholics
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase in oxygen saturation (SPO2) and respiratory rate of the brochial asthma patients. |
Baseline, 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Variation in i) PEFR (Peak flow meter)
ii) FVC, FEV1, FEV1%, PEF (Spirometry)
iii) IgE,
iv) IgM
v) Absolute Eosinophil Count (AEC)
|
24 weeks after 4 weeks follow up |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
11/04/2022 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
· Group A – Experimental group: -Subjects suffering from Shwasa (Bronchial asthma) performing Nadishodhana pranayama for 10 minutes a day at 7 am on empty stomach along with standard Modern & Ayurvedic medicine (Tab. Kantakari GhanVati 500 mg BD) for 6 months – 60 patients · Group B - Control group: - Subjects suffering from Shwasa (Bronchial Asthma) performing Anuloma Viloma pranayama for 10 minutes a day at 7 am on empty stomach along with standard Modern & Ayurvedic medicine (Tab. Kantakari GhanVati 500 mg BD) for 6 months – 60 patients and we will see the relief in symptoms of Shwas (Bronchial Asthma) with follow up of one month. |