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Clinical Trial Details (PDF Generation Date :- Tue, 17 Dec 2019 09:56:17 GMT)

CTRI Number CTRI/2017/02/007754 [Registered on: 01/02/2017] - Trial Registered Retrospectively

Last Modified On 31/01/2017
Post Graduate Thesis Yes
Type of Trial Interventional
Type of Study Drug
Ayurveda
Study Design Randomized, Parallel Group Trial
Public Title of Study A clinical trial to study the effects of two drugs, Vasa Ghanavati & Vasa Avaleha in patients of
Tamaka Shwasa(Bronchial Asthma)
Scientific Title of A Comparative efficacy of Vasa Ghanavati and Vasa Avaleha in the Management of Tamaka
Study Shwasa(Bronchial Asthma)
Secondary IDs if Any Secondary ID Identifier
NIL NIL
Details of Principal Details of Principal Investigator
Investigator or overall
Name Dr Upendra U Zala
Trial Coordinator
(multi-center study) Designation Associate Professor
Affiliation J.S.Ayurveda college, Nadiad Gujarat
Address Department of Rasashashtra & Bhaishajyakalpana, J.S.Ayurveda
college, College road,Nadiad Department of Rasashashtra &
Bhaishajyakalpana, J.S.Ayurveda College,Nadiad Di.Kheda Gujarat
387001
Kheda
GUJARAT
387001
India
Phone 8401824975
Fax 02682520646
Email drupendrazala@yahoo.co.in
Details Contact Details Contact Person (Scientific Query)
Person (Scientific
Name Dr Hansraj Virabhai Barjod
Query)
Designation PG Scholar
Affiliation J.S.Ayurveda college, Nadiad Gujarat
Address Department of Rasashashtra & Bhaishajyakalpana, J.S.Ayurveda
college, College road,Nadiad C-604,Shreeji Enclave, B/H Zalak
Police Chocky, Petlad Road,Nadiad Di.Kheda Gujarat 387002
Kheda
GUJARAT
387001
India
Phone 9978241518
Fax 02682520646
Email barjodhansraj1237@gmail.com
Details Contact Details Contact Person (Public Query)
Person (Public Query)
Name Dr Upendra U Zala
Designation Associate Professor
Affiliation J.S.Ayurveda college, Nadiad Gujarat
Address Department of Rasashashtra & Bhaishajyakalpana, J.S.Ayurveda
college, College road,Nadiad Department of Rasashashtra &
Bhaishajyakalpana, J.S.Ayurveda College,Nadiad Di.Kheda Gujarat

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387001
Kheda
GUJARAT
387001
India
Phone 8401824975
Fax 02682520646
Email drupendrazala@yahoo.co.in
Source of Monetary or Source of Monetary or Material Support
Material Support
> J.S.Ayurveda College & P.D.Patel Ayurveda Hospital, Nadiad
Primary Sponsor Primary Sponsor Details
Name JSAyurveda college Nadiad
Address J.S.Ayurveda college, College road,nadiad 387001 Di.kheda Gujarat
Type of Sponsor Private medical college
Details of Secondary Name Address
Sponsor
NIL NIL
Countries of List of Countries
Recruitment
India
Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email
Investigator
Dr Hansraj Virabhai P.D.Patel Ayurveda P.D.Patel Ayurveda 9978241518
Barjofd Hospital, Nadiad Hospital, College Road, 02682520646
Nadiad Di.Kheda barjodhansraj1237@gm
387001 ail.com
Kheda
GUJARAT
Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics
Committee Committee?
Institutional Ethics Approved 29/07/2015 No
Committee
Regulatory Clearance Status Date
Status from DCGI
Not Applicable No Date Specified
Health Condition / Health Type Condition
Problems Studied
Patients patient having classical symptomatology of
Tamaka Shwasa(Bronchial Asthma), Special
proforma prepared for inclusion of sign &
symptoms of the disease as per Ayurveda and
modern science.
Intervention / Type Name Details
Comparator Agent
Intervention VG vasaghanvati VA vasa VG vasaganvati 300mg 2 tablet
avaleha BD for 28 days VA vasa
avaleha 10gm BD for 28 days
Comparator Agent VG vasaganvati VG vasaganvati 300mg 2 tablet
BD for 28 days
Comparator Agent VA vasa avaleha VA vasa avaleha 10gm BD for
28 days
Inclusion Criteria Inclusion Criteria
Age From 16.00 Year(s)
Age To 60.00 Year(s)
Gender Both

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Details patient having classical symptomatology of Tamaka

Shwasa(Bronchial Asthma), Special proforma prepared for inclusion
of sign & symptoms of the disease as per Ayurveda and modern
science
Exclusion Criteria Exclusion Criteria
Details Patient with associated disease like Heart disease, Tuberculosis,
Hypertension, Diabetes Mellitus, Cancer, HIV, Parenchymal Lung
disease- Lung Collapse, Cardiac asthma, Pleural Effusion,
Pneumothorax, Pregnant women, Lacting mother and any other
chronic severe illness
Method of Generating Computer generated randomization
Random Sequence
Method of On-site computer system
Concealment
Blinding/Masking Open Label
Primary Outcome Outcome Timepoints
pharmaceutical study of VG and VA complited. 3 months
Secondary Outcome Outcome Timepoints
Not yet Not yet
Target Sample Size Total Sample Size=30
Sample Size from India=30
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
Date of First 05/01/2017
Enrollment (India)
Date of First No Date Specified
Enrollment (Global)
Estimated Duration of Years=1
Trial Months=0
Days=0
Recruitment Status of Not Applicable
Trial (Global)
Recruitment Status of Open to Recruitment
Trial (India)
Publication Details Given for the publication
Brief Summary
INTRODUCTION

AYURVEDA IS A NUTSHELL CONSIST OF THREE

PRINCIPAL

1) Hetu : Etiology

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2) Ling : Symptomatology

3) Aushadha : Therapeutics

Etiology here includes the evidence & distance cause of

disease while the symptomatology includes the entire sign &
symptoms of disease & health. The therapeutics includes the
knowledge regarding drug in a total.

In Charaka Samhita has been mentioned chikitsa

chatushpada & shodas kalayukt chikitsa. Here is a dravya /
bhaishajya in a second position

iÉ;g! ÔVya{yupSwata raegI padctuòym!,

gu[vTkar[< }ey< ivkarVyupzaNtye.2. (c· su·-9 / 3)

In classics of Ayurveda, Charaka Samhita is deal more

with medicine has devoted 1st to 12th chapter on materia medica
in ayurveda. In Charaka Samhita drug have been arranged
under fifty mahakashaya group. The methods of administration
of this drug have been described which are very similar to
present best prepress.

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Bhaishajya kalpana may be considered as upkalpana of

kashaya kalpana or ayurvedic pharmaceutics. Bhaishajya
kalpana is a back bone of ayurveda. It is the science, which
convert the raw drugs into effective dosage form, as per need of
drugs administration. The modifactory procedures, which
enhance the drug action increase half life of drug, Improve
potentiality, fulfill patient complaints called as Sanskara.

Panchvidha kashaya kalpana are the primary

formulation but due to less self life, under later period most of
aacharya develop preparation like Avleha Kalpana, Vati
Kalpana, Sneha Kalpana, Sandhana Kalpana etc.

Avleha is that form of drug delivers system in which

absorption start right from oral cavity due to more of
administration. Avleha Kalpana is a tasteful and good
palatability, wide therapeutic applicability, is used since
enhancing period. Nowadays the market of Kalpana is in million
rupees, which shows the popularity of both Kalpana.

Avleha can be preparing by a liquids media as a base

jaggery, honey, ghrita & prakshepa dravya. Here liquids media
is consider as by Sharangdhar Samhita.

KvawadIna< pun> pakad!"nTv< sa rsi³ya,

sae=vlehCy leh> Syat! tNmaÇa

SyaTplaeiNmta. ( za·s<·m·o·-8/1)

Ayurveda comprehence and integrated approach

psyche-soma. The manas (psyche), the Atma(soul) and the

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sharir(body) have been considered as the triplet route of living.

They are then nominally of the both, the manas and sharir is
essential for a health being.

In the normal state the construction of body, that is

dosha, dhatu, malas are supposed to a state of equilibrium as
soon as imbalance in the homeostasis occur pathological
changes in sour causing pain. The vyadhi has been define
Ayurveda system of medicine as a state which the both body
and mind are subjective to pain and misery. The utility of
Ayurvedic science is to help to maintain the health of healthy
individual and cure of disease. Any drug formulation is too
mitigating the disease of a person, both this formulation were
given to patient of Swasa roga to evaluate shwasahara effect.

REVIEW OF PREVIOUS WORK

The research work regarding Avleha Kalpana, Vati Kalpana and

disease Shwasa argument as below:

(1) Dr. Naik A.K et.al, A pharmaceutics and clinical study of

Haritaki leha W.S.R to shwasa, 2001.

(2) Dr.Pandya U.A et.al, A comparative pharmaco clinical study of

kantakari Avaleha and Kantakari Ghana in the management of
Tamak Shwasa, 1999.

(3) Dr. Jarasani A.et.al, A comparative pharmaco clinical study of

Bharangiguda and Bharangyadi arista in the management of
shwasa, 2003.

(4) Dr.Shaiya V. et.al, A comparative study of madhuyukta vasa

swarasa and maricha yavakshara yoga in Tamak shwas,
Hyderabad 1987.

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(5) Dr.Ramnivas J.B.et.al, standardization of Vasa ghrita and its

extract form and their comparative pharmaco-clinical study
W.S.R to Shwasa Roga, Jamnagar 1997.

(6) Dr. Gandhi Piyush et.al, A comparative study of different

formulations of Vasa (Avaleha, Sneha, Sandhana) W.S.R. to its
Shwashar effect Jamnagar 2005.

HYPOTHESIS

Null hypothesis:

Vasa Avleha will not be comparatively more effective in

the management of Tamak Shwasa(Bronchial Asthma) then
that of Vasaghanavati prepare from Vasa swarasa(required for
preparation of similar quantity of same Vasa avleha),and pippli
churna (required for preparation of similar quantity of same
Vasa avleha).

Alternate hypothesis:

Vasa Avleha will be comparatively more effective in the

management of Tamak Shwasa(Bronchial Asthma) then that of
Vasa ghanavati prepare from Vasa swarasa (required for
preparation of similar quantity of same Vasa avleha) and pippali

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churna(required for preparation of similar quantity of same Vasa

avleha).

SIGNIFICANCE OF PRESENT STUDY

1. An attempt to study the pharmaco analytical change in the

ingredients when compounded in to formulations avleha and
ghanavati with special reference to Vasa avleha.

2. It also helps to find out comparative therapeutics efficacy of

both formulations on Tamaka shwasa (Bronchial Asthma).

3. Data generation in support of significance of Avleha kalpana

in pharmaceutical, analytical and clinical aspects.

AIMS AND OBJECTIVES

1. To develop Standard Manufacturing process and Analytical

profile of Vasa ghanavati.

2. To compare clinical efficacy of Vasa Ghanavati and Vasa

Avaleha in the management of Tamaka shawasa (Bronchial
Asthma).

PLAN OF STUDY

The study will be carried out within the following phases

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A. Pharmacognostical study

B. Pharmaceutical study

C. Analytical study

D. Clinically study

1. DRUG REVIEW

The drug review has been carried out to explain the

physiochemical parameters as well as therapeutics properties of
all ingredients.

2. DISEASE REVIEW

In this chapter detailed highlight make about Tamaka shwasa

and is co related with bronchial asthma.

3. KALPANA REVIEW

♦ Concept of vati kalpana and avaleha kalpana

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♦ Requirement for avaleha kalpana

♦ Ingredients and their ratio

♦ Procedure of avaleha kalpana

♦ Avlehpaka siddhi lakshana and pariksha

♦ Tablets preparation and its utility

A) PHARMACOGNOSTICAL STUDY

This study deals with the detail morphological,

macroscopical and microscopical study of each ingredient.

B) PHARMACEUTICAL STUDY

A detailed drug description and preparation of

both the sample of vasa which over led in this section. The
detail of practical procedure regarding preparation of swarasa,
kwatha and ghana are done in this section to salute the
appropriate one. Then vasaghana and vasa avaleha was
prepared with the classical reference from Bhaishajya Ratnavali
(14/37) with slight modification while selecting the sweetening
substances. The details of various practical were the
commented and calibrated in the form of temperature, direction
and yield. In the last calculate cost of final product.

C.) ANALYTICAL STUDY

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In this section physico-chemical analysis of both

samples (formula) will be done. This includes ph, total solid
content, methanol soluble extractive, sugar soluble extractive,
sugar contain, total alkaloid, TLC or HPTLC, Hardness.

D.) CLINICAL STUDY

Safety, efficacy of this formulation that is Vasa

Avaleha and Vasa Ghanavati will be carried out with the help of
clinical trials. The clinical trials carried out by two formulations to
the randomized divided patient in two groups are twenty eight
days. Total thirty (30) patients will be enrolled, fifteen (15)
patients in each group. The patients will be selected to full fill
the inclusion and exclusion criteria.

PLAN OF CLINICAL STUDY

1. CRITERIA FOR INCLUSION

• Patient having classical symptomatology of Tamaka

Shwasa (Bronchial Asthma) may be selected from OPD and
IPD of P.D.Patel hospital, J.S.Ayurved mahavidyalaya Nadiad.

• Both the sex having age between 16 to 60 years.

• Special pro-forma prepared for inclusion of sign and

symptoms of the disease as per ayurveda and modern science.

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2. CRITERIA FOR EXCLUSION

• Age below 16 and above 60 years

• Patient with associated disease like heart disease,

tuberculosis, hypertension, diabetes mellitus, cancer, HIV, and
any secondary severe infection.

• Patients in status asthmatics, patients on

Cortico-Steroids, Persistent respiratory distress, Fever (at
present and or in last 15days), Lower respiratory tract infection,
Parenchymal lung disease – Bronchiectasis, Lung collapse,
Cardiac asthma (Corpulmonale, Cardiomegaly), Pleural
effusion, Pneumothorax.

• Pregnant women

• Lactating mother

• Patient of any other chronic severe illness.

3. CRITERIA FOR WITHDRAWL

• Between the trial periods if any severe complication

develops which required urgent treatment that patient will be
referred for further management.

4. ASSESMENT CRITERIA AND ROUTINE EXAMINATION

• Detail pro forma will be prepared also with detail

history will taking and complete routine physical examination will
be carried out to a certain diagnosed. All the laboratory

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investigation like Absolute Eosinophil Count, Chest X ray,

Breath holding time, PR, RR, Spirometry, Peak flow meter,
ESR, etc parameters will be taken as objective assessment
criteria.

• Asthma control test questionnaire will be utilized for

assessment of treatment outcomes.

• NOTE : During study all the modern drug will be

gradually step by step discontinued and in emergency
patient may be treated with modern drug.

GROUPS

Selected patient will be randomly divided in two groups.

The study will be open lable study.

1. GROUP - 1

40 gms of Vasa avleha 2 times /day orally with luke warm water.

2. GROUP – 2

Vasa ghanavati prepared from Vasa swarasa

(required for preparation of 40 gms of Vasa avleha in Group 1)
2times/day orally along with pippali churna, ghrita and sugar
candy (required for preparation of same quantity of Vasa
avleha.

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POSOLOGY

GROUP 1 : 2 tablets Vasa ghanavati (300mg per tablet)

orally BD with

luke warm water

GROUP 2 : 10 gm Vasa avaleha orally BD with luke

warm water

BHAISHAJ KAL

Morning and Evening (empty stomach)

ANUPAN : warm water

DURATION : 4 week

PATHYA – APATHYA

All selected patient will be advice to avoid the

factor’s (aahara and vihara) which cause Tamaka
Shwasa(Bronchial Asthma) as per our classical reference.

FOLLOW UP

Patient will be reviewed for 15 days after completion of

the treatment.

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CRITERIA FOR ASSESMENT

1. Improvement in signs and symptoms of disease as per

ayurveda texts.

2. Investigations conducted before and after the treatment.

3. P.F.T assessment after and before treatment.

4. The obtained data will be statically analyze and presented

along with explainatory notes, discussion and conclusion.

STATICAL ANALYSIS

The obtained data will be statically analyzed with the

help of student -t-TEST.

CO OPERATION REQUIRED

• Faculty of pharmacy, D.D. University, Collage road,

Nadiad, Gujarat.

• Faculty of pharmacy, Charuset University, Changa,

Gujarat.

• Pharmacognocy department of dravyaguna

• Bio chemistry laboratory, Mahagujarat modern

hospital Nadiad

• Pathology – Mahagujarat moden hospital Nadiad

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• P.D.Patel hospital, J.S.Ayurved Mahavidyalaya

Nadiad

If needed help will be taken from other department of collage

and various advance laboratory with the permission from
concern authority of collage as well as I.P.G.T. & R.A. Gujarat
Ayurveda University, Jamnagar.

REPORTING OF ADR

Adverse drug reaction is observe in the patient will be

registered and duly reported to ADR Cell (pharmacovigilance
cell of GAU).

CONSENT PROCEDURE

Retain inform consent from patient will be taken prior to

the initiation of clinical study in the recruited patient with suitable
provision are withdrawal.

FINANCIAL SUPPORT

This study will be completed within the prescribed

financial limit for the work however, if more is required may be
arranged by Maha Gujarat medical society.

CONFLICT OF INTEREST

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There is no conflict of interest as this study will be done

as a partial fulfillment of the academic requirement of MD (Ayu.)

DECLARATION

This study will be completed within the time limit of

Gujarat Ayurveda University , Jamnagar.

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