| CTRI Number |
CTRI/2017/12/010793 [Registered on: 07/12/2017] Trial Registered Prospectively |
| Last Modified On: |
01/12/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Jivantyadi churna in the management of Tamaka Shwasa |
|
Scientific Title of Study
|
Management of Tamaka Shwasa (Bronchial Asthma) in Children with Jivantyadi Churna and Shwasahara Dashemani Churna - An Open Labelled, Randomized, Comparative Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chuman lal Bhaskar |
| Designation |
MD Second year |
| Affiliation |
Ipgt and ra Jamnagar |
| Address |
OPD No 24 Kaumarbhritya department IPGT and ra Gujarat ayurved University
Jamnagar
India
OPD No 24 Kaumarbhritya department IPGT and ra Gujarat ayurved University
Jamnagar
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9512843829 |
| Fax |
|
| Email |
chumanlalbhaskar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof K S Patel |
| Designation |
Professor and HOD Kaumarbhritya department ipgt and ra Jamnagar |
| Affiliation |
IPGT AND RA JAMNAGAR |
| Address |
Kaumsrbhritya department ipgt and Ra Gujarat ayurved university
Jamnagar 361008
India
Kaumsrbhritya department ipgt and Ra Gujarat ayurved university
Jamnagar 361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9427574566 |
| Fax |
|
| Email |
drkspatel2007@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr V K Kori |
| Designation |
Associate Professor IPGT and RA Gujarat ayurved university |
| Affiliation |
IPGT AND RA JAMNAGAR |
| Address |
Kaumarbhritya department ipgt and ra Gujarat ayurved university
Jamnagar 361008
India
Kaumarbhritya department ipgt and ra Gujarat ayurved university
Jamnagar 361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9374548475 |
| Fax |
|
| Email |
drvkkori@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Director of IPGT @ RA GAU JAMNAGAR |
|
|
Primary Sponsor
|
| Name |
Director IPGT and RA GAU JAMNAGAR |
| Address |
IPGT and RA GAU JAMNAGAR |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Chuman lal Bhaskar |
PG Hospital IPGT and RA Jamnagar |
PG Hospital
Kaumarbhritya
Dept OPD
IPGT and RA
Jamnagar Gujarat
Jamnagar
GUJARAT
Jamnagar
GUJARAT |
9512843829
chumanlalbhaskar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Institute For Post Graduate Teaching And Research Ayurveda Gujarat Ayurved University Jamnagar 361008 PGT/7/-A/Ethics/2017-2018/2093 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients having sign and symptoms of bronchial
asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
in Group A Jivantyadi Churna referance
Astang Hridya Chikitsa sthana Shlok
no 4/43-45 |
18 drugs of Jivantyadi churna named as Jivanti Leptadenia reticulata W & R
Nagarmotha Cyperus rotandus Linn.
Tulsi Ocimum sanctum Linn.
Dalchini Cinnamomnm Cassia (L.)
Badi elaichi Amomum Subulatum Roxb.
Chhoti elaichi Elettaria Cardamomum Maton.
Pushkaramoola Inula racemosa. Hook. F
Chanda Angelica Archangeica Linn
Bhumyamalaki Phyllanthus Fraternus L.
Agaru Acquilaria agallocha Roxb.
Bharangi Clerodendrum Serratum Linn.
Shunthi Zingiber Officinale Roscope.
Shugandhabala Pavonia odorata Willd.
Karkatshringi Pistacia integerrima Stew.
Kachura Curcuma Zedoaria Rosc.
Pippalimoola Piper longum Linn.
Nagakeshar Ochrocarpu Longifolius Benth & Hook.F.
Choraka Angelica glauca Edgew.
|
| Comparator Agent |
In Group B Shwasahara
Dashemani Churna reference
caraka samhita sutra sthan
shlok no 4/37 |
10 content in Shwasahara
Dashemani churna namely
Shati Hedychium spicatum
Pushkara mool Inula racemosa
Amlavetasa Rheum emodi Ela
Elettaria cardamomum Hingu
Ferula narthex Agaru Acquilaria
agallocha Sursa Ocimum
sanctum Tamalaki Phylenthus
niruri Jivanti Laptidinia reticulate
Chanda Angelica glauca |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients of 2 – 12 years of age group of either sex
2 Diagnosed cases of Tamaka Shwasa (Bronchial Asthma) with at least 2 episodes of asthma symptoms during the previous year
3 Patients on other drug therapy will be included only after completion of wash out period of 2 weeks
4 Mild persistent asthmatic patients
5 Patients on other drug therapy will be included only after completion |
|
| ExclusionCriteria |
| Details |
1 Children of age below 2 years and above 12 years
2 Patients with status asthmatics Evidence of active Concomitant Pulmonary Diseases other than
asthma
3 Evidence of requirement of intubations for asthma or had been hospitalized for asthma within one month before Unresolved Sinus Disease or an unresolved upper or lower respiratory tract infection within 4 weeks
4 Concomitant severe de-compensated systemic disease (cardiovascular renal hepatic endocrine hematological neurological immunological). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
relieve in the sign and symptom of shwasa roga
or Bronchial asthma |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To prevent the recurrence of attack of
breathlessness
To increase the immunity against allergens |
8 weeks |
|
|
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 3 |
|
Date of First Enrollment (India)
|
14/02/2018 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
No any related publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Present clinical trial is randomised clinical trail on Tamaka Shwsa (Bronchial Asthma) in children of
either sex between 2 to 12 years of age. Study will evaluate the role of jivantyadi Churna and Shwasahara
Dashemani churna. Intervational drug isjivantyadi Churna while comparator agent is Shwasahara Dashemani churna.
Study is going to be conducted with primary aim to relieve the symptom of childhood asthma
Till date 30 patients will be registered in clinical trial
As trial as in progress final conclusion or remarks can be drawn only after the completion of clinical
trial
|