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CTRI Number  CTRI/2024/04/065740 [Registered on: 16/04/2024] Trial Registered Prospectively
Last Modified On: 23/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   A clinical trial to study the effect of a drug agastya haritaki in post COVID19 and non COVID 19 patients of tamaka shwas (Bronchial asthma) 
Scientific Title of Study   A comparative clinical study on the efficacy of Agastya Haritaki in post COVID-19 & non COVID-19 subjects of Tamaka shwas (Bronchial 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  Shalini 
Designation  Assistant Professor 
Affiliation  Institute of medical sciences, BHU 
Address  Department of Kayachikitsa , Faculty Of Ayurveda, IMS, BHU

Varanasi
UTTAR PRADESH
221005
India 
Phone  9785520474  
Fax    
Email  dr.shalini@bhu.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Shalini 
Designation  Assistant Professor 
Affiliation  Institute of medical sciences, BHU 
Address  Department of Kayachikitsa , Faculty Of Ayurveda, IMS, BHU


UTTAR PRADESH
221005
India 
Phone  9785520474  
Fax    
Email  dr.shalini@bhu.ac.in  
 
Details of Contact Person
Public Query  
Name  Shalini 
Designation  Assistant Professor 
Affiliation  Institute of medical sciences, BHU 
Address  Department of Kayachikitsa , Faculty Of Ayurveda, IMS, BHU


UTTAR PRADESH
221005
India 
Phone  9785520474  
Fax    
Email  dr.shalini@bhu.ac.in  
 
Source of Monetary or Material Support  
Institute of Eminance, BHU, VARANASI 
 
Primary Sponsor  
Name  Institute of Eminence 
Address  Office of Registrar (Development), Banaras Hindu University, Varanasi 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shalini  Sir Sunderlal Hospital, IMS, BHU  OPD/IPD of Kayachikitsa, Ayurveda Wing, Sir Sunderlal hospital, IMS, BHU
Varanasi
UTTAR PRADESH 		 9785520474

dr.shalini@bhu.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J452||Mild intermittent asthma. Ayurveda Condition: TAMAKASVASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Agastya Haritaki, Reference: Charak Chikitsa 18/57-62 pg no 539, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: Group A - 50 patients of tamak shwas
2Intervention ArmDrugClassical(1) Medicine Name: Agastaki Haritaki , Reference: Charak Chikitsa 18/57-62 pg no 539, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: Group B - 50 patient of tamak shwas (bronchial asthma) documented prior COVID-19 (at least more than 2 weeks) as evidenced by detection of SARS-CoV-2 Real Time PCR or antigen in nasopharngeal swab or positive antibody test for COVID-19
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patient with stable Bronchial Asthma (Tamaka shwasa) (as per WHO GINA Guideline) for at least 6 weeks prior to study entry.

2. Positive test of reversibility:

• Symptomatic patients - an improvement of 60 L/min or ≥20% in PEFR, 10 minutes after the inhalation of 200 mcg of Salbutamol.

• Asymptomatic patients - 60 L/min or ≥20% fall in PEFR by provocation with 5-10 minutes of physical exercise, followed by reversal upon inhalation of 200 mcg of Salbutamol, when assessed after 10 minutes.

3.Patient willing and able to participate for 16 weeks.
 
 
ExclusionCriteria 
Details  1. Patients with PEFR less than 50% and/ or FEV1 more than 50% of the predicted value.

2. Patients with evidence of malignancy.

3. Patients present with co-morbid disorders. (DM, TB, RA, Ca etc.).
Patient with poorly controlled Diabetes Mellitus (HbA1c more than10%).

4. Patients with poorly controlled Hypertension (i.e. Systolic more than 160 mm of Hg and Diastolic more than 100 mm of Hg)

5. Patients on prolonged ( more than 6 weeks) medication with corticosteroids, bronchodilators, mast cells stabilizers, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study.

6. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal disorders, etc.)

7. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia .

8. Symptomatic patients with clinical evidence of Heart failure.

9. Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) more than 2 times upper normal limit) or Renal Disorders (defined as S. Creatinine more than1.2mg/dL), Severe Pulmonary Dysfunction, or any other condition that may jeopardize the study.

10. H/o hypersensitivity to the trial drug or any of its ingredients.
11. Pregnancy or lactating women.
12. Positive SARS-CoV-2 Real Time PCR or antigen in nasopharyngeal swab at screening visit.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in the clinical symptoms (Asthma Control Questionnaire).   12 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Change in the objectives/ laboratory parameters.   12 weeks 
 
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 2/ Phase 3 
Date of First Enrollment (India)   23/04/2024 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 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  


Asthma is a chronic disease characterized by recurrent attacks of breathlessness and wheezing, which vary in severity and frequency from person to person. WHO estimates show that 300 million people currently suffer from asthma. Asthma deaths will increase in the next 10 years if urgent action is not taken.[ Bousquet J, Khaltaev N et.al] Asthma cannot be cured but proper diagnosis, treatment and patient education can result in good asthma control and management. For effective control, it is essential to make medications affordable and available, especially for low�’income families. 
On the basis of similar clinical features, Bronchial Asthma can be correlated with Tamaka shwas, a disease described under the heading of five types of Shwasa in Ayurvedic classics. According to Ayurveda, Shwasa is a Kapha�’Vataja disease, which is originated from Pittasthana. According to Ayurveda, formation of Ama is the seed for the development of future disease. The acute attack of disease appears whenever there is an obstruction of the normal passage of Pranavayu. Once the obstruction is removed, and Vayu start travelling in its normal path symptom, (breathlessness, cough etc.,) are abolished. Considering the Ayurvedic concept of treatment of Tamaka shwas it was decided to select an herbal Preparation “Agastya Haritaki ” for the management of bronchial asthma.

 
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