| 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
|
|
|
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
|
|
|
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. |