| CTRI Number |
CTRI/2024/02/063131 [Registered on: 26/02/2024] Trial Registered Prospectively |
| Last Modified On: |
22/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Role Of Pushkarmool Churana And Bhastrika Pranayam In The Management Of Tamakswash W.S.R To
Brochial Asthma.
|
|
Scientific Title of Study
|
A Comparative Clinical Study On Effect Of Pushkarmool Churana And Pranayam 0n Tamakswash W.S.R To
Brochial Asthma. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gurmeet SinghGirn |
| Designation |
Ayurvedic Medical Officer |
| Affiliation |
Guru Ravidas Ayurvedic University ,Hoshiarpur,Punjab |
| Address |
Incharge 2,Store and Supply ,Government Ayurvedic Pharmacy and Store ,Patiala,Punjab
vpo kharkan Kala,hoshiarpur, punjab
Patiala
PUNJAB
147001
India |
| Phone |
9501688775 |
| Fax |
|
| Email |
gumiez@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neerja Sharma |
| Designation |
Professor,Department of Swasthavritta and Yoga |
| Affiliation |
Dhanwantri Ayurvedic College |
| Address |
Dhanwantri Ayurvedic College,Chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
9041584513 |
| Fax |
|
| Email |
neerjasharma2966@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gurmeet Singh Girn |
| Designation |
Ayurvedic Medical Officer |
| Affiliation |
Guru Ravidas Ayurvedic University |
| Address |
Incharge 2 ,Store and supply ,Government ayurvedic pharmacy and store ,Patiala ,punjab
VPO kharkhan ,hoshiarpur ,Punjab ,India
Hoshiarpur
PUNJAB
147001
India |
| Phone |
9501688775 |
| Fax |
|
| Email |
gumiez@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic Pharmacy and Store ,Patiala, Punjab |
|
|
Primary Sponsor
|
| Name |
Dr Gurmeet Singh Girn |
| Address |
Government Ayurvedic Pharmacy and Store ,Patiala, Punjab |
| 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 |
| DrGurmeet Singh Girn |
Government Ayurvedic hospital |
Department of Kayachikitsa ,Room No.7,Government Ayurvedic hospital ,Sher-E-Punjab Market
Patiala
PUNJAB |
9501688775
gumiez@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GuruRavidasAyurvedicUniversityHoshiarpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J453||Mild persistent asthma. Ayurveda Condition: TAMAKASVASAH, (2) ICD-10 Condition:J984||Other disorders of lung. Ayurveda Condition: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Bhastrika Paranayam, Pathya/Apathya:no, Pathya:, Apathya: | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pushkarmool churan, Reference: Charak samhita, sutrasthana,Chapter 25, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with intermittent and mild persistent controlled bronchial asthma.
The selection of the patient will be irrespective of their Sex, Caste, Religion, Socioeconomic status.
Patient ready to give written consent.
uncomplicated cases of Bronchial Asthma.
|
|
| ExclusionCriteria |
| Details |
Patient suffering from Tuberculosis ,Cardiac aliments, Endocrine disorder like diabetic mellitus and Thyroid gland disorder .
Other complicated respiratory diseases having any organic lesion such as tumor or any anatomical defect in airway.
Pregnant or lactating women. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in clinical features of Tamak Shwasa like Shwasa,Kasa,Kaphanishkasan,KanthGhurHhur,Uroguruta,Shopha,Asinolabhtesaukhyam etc. |
0day,15day,30day,45day,60day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Normalization of in spirometry test of lung |
0thday,60thday |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3 |
|
Date of First Enrollment (India)
|
10/03/2024 |
| 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 Applicable |
| 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
|
Tamak swash is the most common non communicable respiratory
disease affecting all age group of both sex .It is considered as a
Bronchial asthma in modern science. Tamak swash is increasing due to
excessive pollution and overcrowding. The clinical features of Tamak swash
are Shwasa (Breathlessness), Kasa (Cough), Kapha Nishkasan
(Expectoration), Kanth Ghurghur (Wheezing), Urogurutwa (Heaviness of
Chest), Shopha (Edema), Asinolabhtesaukhyam etc. Ayurveda classics and
Yoga describes wide range of medicines and breathing techniques in the
treatment of Shwasa Roga. In Charak samihita, much emphasis is given on
the role of Pushkarmool in Swash treatment. According to Yoga Bhastrika
Pranayama quickly arouses kundalini,It is pleasant and beneficial, and removes
obstruction due to excess mucus accumulated at the entrance to brahma nadi and
that produces many systemic and psychological effects in the body, specifically
on the respiratory system ,it is considered best for the treatment of Tamak
swash. So a clinical study will be conducted on probable case of Tamak swash
for the period of 60 days. Patients will be divided into two groups ,Each group
consists of 50 patients. Group A will be treated with Ayurvedic medicine
Phuskarmool churan, Group B will be treated with Phuskarmool and Bhastrika
pranayam. Observation on parameters will be done on 0th,15th,30th,45th,60th Day
of the treatment .Analysis of symptoms will be done statistically on the basis
of results obtained in objectives and subjective parameters. Conclusion will be
done on the basis of analysis of the data obtained .
|