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CTRI Number  CTRI/2024/03/064423 [Registered on: 19/03/2024] Trial Registered Prospectively
Last Modified On: 13/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Pushkaramoola Churna with Bharangikanadi Kashaya and Vamana Karma in Management of Tamaka Shwasa with special reference to Bronchial Asthma 
Scientific Title of Study   A Randomised Comparative Clinical study to Evaluate the Efficacy of Pushkaramoola Churna with Bharangikanadi Kashaya and Vamana Karma in the Management of Tamaka Shwasa with Special Reference to 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  Dr Sruthi K 
Designation  M.D(Ayu) scholar 
Affiliation  Banaras Hindu University 
Address  Department of Kayachikitsa Institute Of Medical Sciences Banaras Hindu University Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  9995467815  
Fax    
Email  sruthisudhakar.k@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shalini 
Designation  Assistant Professor 
Affiliation  Banaras Hindu University 
Address  Department of Kayachikitsa Institute Of Medical Sciences Banaras Hindu University Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  9785520474  
Fax    
Email  dr.shalini@bhu.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Shalini 
Designation  Assistant Professor 
Affiliation  Banaras Hindu University 
Address  Department of Kayachikitsa Institute Of Medical Sciences Banaras Hindu University Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  9785520474  
Fax    
Email  dr.shalini@bhu.ac.in  
 
Source of Monetary or Material Support  
Department of Kayachikitsa, Faculty of Ayurveda, IMS BHU Varanasi Uttarpradesh 
 
Primary Sponsor  
Name  Department of Kayachikitsa 
Address  Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh India 
Type of Sponsor  Research institution and hospital 
 
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 Sruthi K  Sir Sunderlal Hospital  OPD No 21-22, Department of Kayachikitsa Indian Medicine Wing Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH 		 9995467815

sruthisudhakar.k@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee IMS BHU  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, (2) ICD-10 Condition:J453||Mild persistent asthma. Ayurveda Condition: TAMAKASVASAH, (3) ICD-10 Condition:J454||Moderate persistent asthma. Ayurveda Condition: TAMAKASVASAH, (4) ICD-10 Condition:J459||Other and unspecified asthma. Ayurveda Condition: TAMAKASVASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-vamana-karma/ pracCardanam, वमन-कर्म/ प्रच्छर्दनम् (Procedure Reference: Charaka samhita,Susruta samhita, Procedure details: 1.Deepana and pachana - Shunthi churna (4g) with luke warm water for 3 days before meal Twice in a day 2.Snehapana with Murchita Gou gritam - in order 30ml,60ml,90ml,120ml,150ml,180ml,210ml Till samyak snigdha lakshana (not more than 7 days) 3.Sarvanga abhyanga and swedana with Tila taila and saindhava for 2 days 4.Vamana karma - Akantapana -Go Dugdha - 2L Vamana dravya - Madanaphala churna– 5g Vacha churna– 3g Saindhava lavana – 2g 5.Dhoomapana–With varti made of kantakari and haridra)
(1) Medicine Name: Bharangikanadi Kashayam, Reference: Sahasrayogam-Kasahayaprakaranam(swasakasa), Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 50(ml), Frequency: bd, Duration: 3 Months
(2) Medicine Name: Pushkaramoola Choornam, Reference: Charaka Samhita/Sutra sthanam, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Duration: 3 Months
2Intervention ArmDrugClassical(1) Medicine Name: Bharangikanadi Kashayam, Reference: Sahasrayogam-Kasahayaprakaranam(swasakasa), Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Maricha churna-1gram), Additional Information: Prepare Kashaya on low flame in an open lid vessel by boiling 1 part of Kashaya churna (25g) in 8 times (200ml) water and reduced to 1/4th of initial quantity (50ml)
(2) Medicine Name: Pushkaramoola Choornam, Reference: Charaka Samhita/Sutra sthanam, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information:
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Patients willing to participate in above trial and given written consent
2.Patient of either sex greater than 20 years and less than 50 years
3.Patient with stable bronchial asthma as per WHO GINA Guidelines for at least 6 weeks prior to study entry.(Episodes of Wheezing, shortness of breath, Chest tightness, and cough, that vary over time and in intensity, together with variable expiratory airflow limitation - GINA definition of Bronchial asthma)
Positive test of reversibility: -
a.Symptomatic patients - an improvement of 60L/min or more than 20% in PEFR, 10 minutes after the inhalation of 200mcg of salbutamol
b.Asymptomatic patients – 60L/min or more than 20% fall in PEFR by provocation with 5-10 minutes of physical exercise, followed by reversal upon inhalation of 200mcg of salbutamol, when assessed after 10 minutes.
4.FEV1 more than 50% and less than 80%
5.FEV1 and FEV ratio less than 70%
6.Patient presenting with features of Tamaka shwasa as in ayurvedic classical text books
 
 
ExclusionCriteria 
Details  1.Patients with PEFR less than 50% and or FEV1 less than 50% of predicted value
2.Pregnant and lactating women
3.Patient with poorly controlled diabetes mellitus (HbA1c greater than 8%)
4.Patient with poorly controlled Hypertension (Systolic greater than 160 mm Hg and Diastolic greater than 100 mm of Hg)
5.Patients on prolonged (more than 6 weeks) medication with corticosteroids, bronchodilators, mast cells stabilizers, antidepressants, anticholinergics, or any other drugs that may have an influence on the outcome of the study.
6.Smoker or alcoholic or drug abusers
7.Patients who have a past history of Atrial fibrillation, Acute Coronary Syndrome, Myocardial Infraction, stroke or severe Arrhythmia in last 6 months
8.Patient having systemic illness necessitating long term drug treatment like TB, carcinoma, endocrine disorders, concurrent major liver or renal disorders, psychological disorders, neurological disorders like epilepsy, meningitis, stroke etc.
9.Patients who have completed participation in any other clinical trial during the past 6 months
10.Patient having pulmonary diseases other than asthma
11.Patient having SPO2 less than 90%
12.Emergency patients requiring O2 inhalation
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in subjective criterias;
1.Asthma Control Test
2.Reduction signs and symptoms of disease. The main signs and symptoms in study are as follows;
Frequency of shwasa vega (frequency of breathing difficulty attacks)
Duration of attack
Kasam (cough)
Kapha Nishthivanam (Expectoration)
Rudhho Ghur-ghurakam (Wheezing)
Urashoola/Parshvashoola (Pain at the chest region)
 		 Treatment period – 3 months
Follow up period – on every 15th day
 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in following objective criterias;
1.Pulmonary function test- Spirometry
a.Forced expiratory volume in 1 second (FEV1)
b.Forced vital capacity (FVC)
c.FEV1/FVC
2.Breath holding time
3.Hematological investigations
(CBC, Absolute Eosinophil Count, LFT, RFT) 		 Treatment period – 3 months
Follow up period – on every 15th day
 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 
Date of First Enrollment (India)   01/04/2024 
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="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  

Aim of study

  To Assess the Clinical Efficacy and Safety of Combination of Pushkaramoola Churna with Bharangikanadi Kashaya and Vamana karma in the Management of Tamaka Shwasa with Special Reference to Bronchial Asthma.

Objectives of study 

To study different breathing disorders described in Ayurvedic classics with special reference to tamaka swasa

To study and analyse Ayurvedic management of tamaka swasa and latest scientific researches on it

To evaluate the effect of Pushkaramoola churna with Bharangikanadi kashaya along with Vamana karma in tamaka swasa

To To evaluate the effect of Pushkaramoola churna with Bharangikanadi kashaya without Vamana karma in tamaka swasa

To To compare the effect of Pushkaramoola churna with Bharangikanadi kashaya with and without Vamana karma

Study design

A total of 70 Patients will be randomly divided into 2 groups as follows-

Group A – will be administer with Pushkaramoola churna-2g and Bharangikanadi Kashaya (50ml twice in a day, morning and evening on empty stomach)

Group B – will be administer with Vamana karma followed by samana therapy -  Pushkaramoola churna – 2g with Bharangikanadi Kashaya  (50ml twice in a day, morning and evening on empty stomach)

Time line -  Treatment period – 3 months

                     Follow up period – on every 15th day

                          

 
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