“ Role of Markatbija churn on Respiratory Rate in Tamak Shvasa with special reference to Bronchial Asthmaâ€
- Conditions
- Moderate persistent asthma. Ayurveda Condition: TAMAKASVASAH, (2) ICD-10 Condition: J454||Moderate persistent asthma. Ayurveda Condition: TAMAKASVASAH,
- Registration Number
- CTRI/2022/03/040712
- Lead Sponsor
- Government ayurved college and hospital
- Brief Summary
After clearance from Institutional Ethics Committee of Government ayurved college and hospital Nagpur 60 subjects of Tamak Shvasa were recruited from OPD and IPD of Government ayurved college and hospital Nagpur.
During the informed consent process the subjects were given enough time to read the patients information sheet and consent form (ICF), subjects were also given freedom to ask the questions and all the questions were answered. If He/She agrees for the participation in the study and if found fit to include during screening then he was recruited in the study. This visit was called as screening visit.
On the screening visit, after written informed consent, screening of subjects on the Basis of clinical assessment for Peak Expiratory Flow Rate, sustained maximal inspiration, Respiratory Rate and investigations like ECG, CBC ,ESR , chest X-ray along with symptoms of Tamak Shvasa and fulfilling the diagnostic criteria, If all the inclusion criteria is YES and all the exclusion criteria is NO then subjects will be included. If Peak Expiratory Flow Rate is <60L/min and Respiratory rate is > 28/ min .
Subjects were then undergo general and systemic examination clinical symptoms of Tamak Shvasa was assessed and recorded in the Case record form. Study design will be Randomised Control Trial.
In which two different groups of drugs were used. Out of which one is control drug and other is trial drug. For that subjects were assessed clinically and are divided into two groups.
Control group. Trial group
1. Tablet Deriphylline Retard 150mg. Markatbija churn 5gm
2. TDS. BD
3. with water. With ghrit
4. After meal. Before meal
Duration of treatment-30 days
Subjects will be called for follow up visit ( i. e , 0,15 ,30 days respectively) on every follow up visit subjects undergo general and systemic examination, assessment of clinical symptoms, assessment scale, and physical characters was done on every follow up visit.
Patients and investigators global evaluation for overall improvement was done at the end of the study. Tolerability of the trial medicine was assessed by the investigators and patients at the end of the study. All the patients were closely monitored for any adverse events/adverse drug reactions.
Based on the above study procedures observations were made and recorded in the Case record form for each subject at every follow up. Subjects were assessed for improvement in clinical parameters on Tamak Shvasa.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 60
- Patient of Tamak Shvasa presenting the clinical features highlighted in classical literature will be randomly irrespective of sex , caste , religion and socio economical status.
- Patient of Tamak Shvasa ageing in between 16 to 60 years will be considered.
- Patient from mild to moderate exacerbation of bronchial asthma.
- Positive test of reversibility- a) symptomatic patients- An improvement of 60 L / min or > 20 % in PEFR 10 min after inhalation of bronchodilator ( salbutamol ) .
- b) Asymptomatic patient 60 L / min or > 20 % fall in PEFR by provocation with physical exercise ( brisk walking for 5-10 min ) followed by reversal upon in Inhalation of bronchodilator ( salbutamol) when assessed after 10 min .
- Heemoglobin >10 gm%.
- Patient willing and able to participate for 4 weeks.
- Patient showing symptoms, signs and medical history of bronchial asthma will be included.
Patient with active lung disease, patient with lung disease other than bronchial asthma, patient who had major surgeries within 2 weeks prior to screening visited , patient with evidence of malignancy, patient with severe asthma exacerbation, pregnant or lactating , patient with poorly controlled hypertension ( >160/100 mmhg) , patient with uncontrolled diabetes mellitus ( blood sugar fasting >130 mg /dl and post meal 250 mg /dl ).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 2. To study the effect of Deriphylline retard in the management of Tamak Shvasa specifically on respiratory rate , peak expiratory flow rate, sustained maximal inspiration and MRC dyspnoea scale. 18 months 3. To compare the effect of markatbija churn with tablet Deriphylline retard with respect to respiratory rate , peak expiratory flow rate , sustained maximal inspiration and MRC dyspnoea scale. 18 months 1.To evaluate the efficacy of markatbija churn in management of Tamak Shvasa specifically on respiratory rate , peak exploratory flow rate, sustained maximum inspiration and MRC dyspnoea scale. 18 months
- Secondary Outcome Measures
Name Time Method 1.To study Tamak Shvasa in detail from Ayurvedic perspective. 2. To study bronchial asthma with modern point of view.
Trial Locations
- Locations (1)
Government ayurved college and hospital
🇮🇳Nagpur, MAHARASHTRA, India
Government ayurved college and hospital🇮🇳Nagpur, MAHARASHTRA, IndiaSandhya SharmaPrincipal investigator8103969434sandhyasharma281@gmail.com