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CTRI Number  CTRI/2020/03/024081 [Registered on: 19/03/2020] Trial Registered Prospectively
Last Modified On: 27/02/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Bharngyadi avleha and Vasadi kashaya in dry cough 
Scientific Title of Study   A clinical study of Bharangyadi Avleha & Vasadi Kashaya in management of Vatika Kasa w.s.r. Tropical pulmonary Eosinophilia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrVivek Dalal 
Designation  MD Scholar in Department of kayachikitsa 
Affiliation  Shri Narayan Prasad Awasthi Government Ayurved College Raipur 491010 Chhattisgarh India 
Address  Shri Narayan Prasad Awasthi Government Ayurved College Raipur
OPD no 2 & 18 and IPD of department of Kayachikitsa
Raipur
CHHATTISGARH
492010
India 
Phone  7015351632  
Fax    
Email  vivekdalal.com@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrSatyadev Khichariya 
Designation  lecturer in Department of kayachikitsa 
Affiliation  Shri Narayan Prasad Awasthi Government Ayurved College Raipur 
Address  Shri Narayan Prasad Awasthi Government Ayurved College Raipur
OPD No 2 & 18 and IPD of department of kayachikitsa
Raipur
CHHATTISGARH
492010
India 
Phone  9826196400  
Fax    
Email  drkhichariya@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrVivek Dalal 
Designation  MD Scholar in Department of kayachikitsa 
Affiliation  Shri Narayan Prasad Awasthi Government Ayurved College Raipur 491010 Chhattisgarh India 
Address  Shri Narayan Prasad Awasthi Government Ayurved College Raipur
OPD no 2 & 18 and IPD of department of Kayachikitsa
Raipur
CHHATTISGARH
492010
India 
Phone  7015351632  
Fax    
Email  vivekdalal.com@gmail.com  
 
Source of Monetary or Material Support  
Shri Narayan Prasad Awasthi Government Ayurved College Raipur- 492010 (chhattisgarh) 
 
Primary Sponsor  
Name  Department of Kayachikitsa  
Address  Shri Narayan Prasad Awasthi Government Ayurved College Raipur 
Type of Sponsor  Other [Shri Narayan Prasad Awasthi Government Ayurved College Raipur] 
 
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 
DrVivek dalal  Shri Khudadad Doongaji Government Ayurved Hospital Raipur  OPD No 2 & 18 & IPD of Department of Kayachikitsa Shri Khudadad Doongaji Government Ayurved Hospital Raipur
Raipur
CHHATTISGARH 
7015351632

vivekdalal.com@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Goverment Ayurved College, Raipur (chhattisgarh)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J984||Other disorders of lung,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BHARANGYADI AVLEHA  Dose- 12 gm ( in Equal Divided Dose ) BDS Orally for 60 days Follow Up- 30 Days  
Comparator Agent  BHARANGYADI AVLEHA & VASADI KASHAYA  Dose - 12 gm (in Equal Divided Dose) BDS with Vasadi Kashaya (20 ml ) Orally for 60 days . 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients between age group of 16 years to 60 years.
2.Patients were selected on the basis of sign and symptoms as described in classics. 
 
ExclusionCriteria 
Details  1.Below age of 16 years and above age of 60 years.
2.Cases associated with other respiratory disorders i.e. bronchial carcinoma, COPD, Cases of tuberculosis
Diabetes Mellitus, Severe Hypertension & other chronic cardio -Vascular disorders, chronic Renal failure
3.Pregnant women
4.Any other Serious disease i.e. HIV, Cancer
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.To reduce the number of elevated eosinophil count
2.To reduce the symptoms of Vatika kasa as mentioned in classics. 
60 days 
 
Secondary Outcome  
Outcome  TimePoints 
To inprove the quality of life of patients by reducing the symptopms  60 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 1/ Phase 2 
Date of First Enrollment (India)   01/04/2020 
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="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)?  

Brief Summary  

Ayurveda, the science of life, is one of the ancient science of the world. It is believed that Ayurveda came into existence along with the existence of the human race. 21st century although looking like a developed era, in fact is a disease epidemic worldwide. The evolution of human being from the primitive life to this civilized modern world took millions of years. During this course of evolution, the human race has seen a great change in their lifestyle with great social and cultural evolution. Though human being have been able to achieve a lot through the development of new technologies and discovery of new things, the most and universally encountered challenge has always been related to health, one that has affected the society since time immemorial. This desire for long and healthy life has been the driving force for the curious and anxious human mind. This quest led the human race to try and test many things ranging from medicinal plants, animal products, minerals and also many rituals and practices. As mentioned by Charaka, desire for life is the most important of all the three quests and desire. This desire ledto the discovery of the healing properties of nature. The shift of the human race from the vanasprastha jeevan to gramya jeevana led into the increment in suffering. The change in their lifestyle was one of the most important cause. This drastic change and shift in their lifestyle was a challenge to the seers too. With the passage of time, the human civilization became afflicted with many sharirika (Physically) and manasika vikruti(Mentally disease). These afflictions caused the human to suffer more. Thus the cure them was not the only solution. Prevention of the diseases to appear again was one important challenge. Unlike other medical practices, where major emphasis is given in the curative aspect, Ayurveda has emphasized on the preventive aspect of diseases with the main goal of maintenance of health  one of the two objectives. Health, according to Ayurveda, is the homeostasis of the dosha, dhatu and mala. These three entities are considered the moola of the sharira

 

 

At the present time, disorders related to respiratory system has increased greatly and KASA (Dry) is also one of these disorders.  According to Ayurveda, it appears as an independent disease and sometimes as a symptom of other diseases. The characterization of Kasa is that it is an attempt to remove foreign matter in the respiratory tract and inflammation in the respiratory tract.  It turns out that this is Kasa.  In the meaning of the word Kas, the sign of not neglecting it is hidden.  Acharya Charaka has said this in the end by instructing the five distinctions of Kaas. That is, Kasa disease is going to cause the decay of the body if it is neglected.

India is a tropical and developing country.  With the increase of modernization and industrialization, the environment is also becoming polluted due to which there is a continuous increase in air pollution.  And the best quality of air is being decreasing day by day .  And due to this, respiratory diseases are also increasing.  Kasa is also one of these.  Which arises from the entry of heterogeneous substances into the respiratory system.  According to Ayurveda opinion, we can call it Vatika kasa .  According to modern belief, the symptoms of this  disease are similar to those of Tropical Pulmonary Eosinophilia (TPE).

 

 

 

Basis of topic selection

In this way of modern relaxed lifestyle, mental stress and competition, humans have invited many kinds of sufferings themselves.  The good quality of food, water, air determines human health.  But in this era of modernization and industrialization, the environment is becoming polluted, dust, smoke, vapor are constantly coming out of these industries.  By which the atmosphere contains Co, CO2, SO, etc. gases.  Due to which, due to air pollution, its quality is being destroyed.  The respiratory rate of a healthy human is 16 - 18 breaths per minute.  This action makes the respiratory system (pranavam strotas) more susceptible to disease.  Kasa is generated by irritation  in the respiratory system by dust ,fumes, vapours etc. Vatika kasa which we can call Dry cough  is very similar to Tropical pulmonary Eosinophilia.  In modern medical science, diethylcarbamazine is used for its treatment, which suppresses disease till taking the drug.  But after stopping the drug, the disease reoccur.  Therefore, according to modern reflection, the best medicine is needed for this disease, because the prevalence of this disease is also increasing due to increasing environmental pollution. 

 

Basis of Medicine selection

For the treatment of Tropical pulmonary eosinophilia as a medicine  Bharngyadi avaleh mentioned in the fifth  chapter of the Gad Nigraha ( in avleha form) &  Vasadi Kashaya described in Sharangadhar Samhita 9 (in decoction form )  are being used . these medicines are prepared from herbal medicinal ingredients. No any complications and harmful effect are described in ayurveda Samhita’s about above medicinal herbal formulations . Hence this medicines are used to treat Tropical pulmonary eosinophilia (Vatika Kasa ) safely & effectively.

 
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