| CTRI Number |
CTRI/2017/04/008282 [Registered on: 03/04/2017] Trial Registered Prospectively |
| Last Modified On: |
07/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of Shwasahara Dashemani Yog in the Tamaka shwasa
Effect of shwasahara dashemani on tamaka shwasha
|
|
Scientific Title of Study
|
A Comparative study of Shwasahara Dashemani in the Management of Tamaka Shwasa(Bronchial Asthma)in Children-A randomized open label clinical Trail |
| Trial Acronym |
EOSDOTS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kuldeep Kumar Soni |
| Designation |
MD Second Year |
| Affiliation |
IPGT and RA JAMNAGAR |
| Address |
PG boys hostel Room no 72 IPGT and ra Gujarat ayurved University Jamnagar
Jamnagar
361008
PG boys hostel Room no 72 IPGT and ra Gujarat Ayurved University Jamnagar
Jamnagar
361008
Jamnagar
GUJARAT
361008
India |
| Phone |
8866359397 |
| Fax |
|
| Email |
dr.kuldeepkumarsoni@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof K S Patel |
| Designation |
Profesar and HOD Kaumarbhritya department ipgt and ra Jamnagar |
| Affiliation |
IPGT AND RA JAMNAGAR |
| Address |
Kaumsrbhritya department ipgt and Ra Gujarat ayurved university Jamnagar
Jamnagar
361008
Kaumarbhritya department ipgt and Ra Gujarat ayurved university Jamnagar
Jamnagar
361008
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 Profesar IPGT and RA Gujarat ayurved university |
| Affiliation |
IPGT and RA JAMNAGAR |
| Address |
Kaumarbhritya department ipgt and ra Gujarat ayurved university Jamnagar
Jamnagar
361008
Kaumarbhritya department ipgt and ra Gujarat ayurved university Jamnagar
Jamnagar
361008
Jamnagar
GUJARAT
361008
India |
| Phone |
9374548475 |
| Fax |
|
| Email |
drvkkori@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
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 |
| Dr Kuldeep Kumar Soni |
OPD NO 24 IPGT AND RA JAMNAGAR |
OPD NO 24 KAUMARBHRITYA DEPARTMENT IPGT AND RA JAMNAGAR GUJARAT
Jamnagar
GUJARAT |
8866359397
dr.kulderpkumarsoni@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee IPGT and RA GAU Jamnagar |
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 Shwasahara Dashemani Avaleha referance carak samhita sutra sthan slok no 4/37 |
10 content in Shwasahara Dashemani Avaleha 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 Honey Sharkara
DOse according to sharamgdhar samhita as per rule in children
Time period 6 weeks
Route of drug is orally |
| 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
Dose according to Sharangdhara samhita as par rules in children
Duration 6 weeks
Route of drug is orally |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Patients of 2 – 12 years of age of either sex.
Diagnosed cases of Tamaka Shwasa with at least 2 episodes of asthma symptoms during the previous year.
Mild persistent asthmatic patients.
Patients on other drug therapy will be included only after completion of wash out period of three weeks.
|
|
| ExclusionCriteria |
| Details |
Children of age below 2 years and above 12 years.
Patients with status asthmatics.
Evidence of active Concomitant Pulmonary Diseases other than asthma.
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 2 weeks.
Concomitant severe systemic disease (cardiovascular, renal, hepatic, endocrine, haematological, neurologicaletc.)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| relieve in the sign and symptom of shwasa roga or Bronchial asthma |
Drug trail time 6 weeks
Follow up time 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To prevent the recurrence of attack of breathlessness
To increase the immunity against allergens |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/04/2017 |
| Date of Study Completion (India) |
14/03/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
No any related publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
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 Shwasahara Dashemani Avaleha from caraka samhita sutra sthan and Shwasahara Dashemani churna from caraka samhita sutra sthan. Intervational drug is Shwasahara Dashemani Avaleha 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 50 patients are registered in clinical trial As trial as in progress final conclusion or remarks can be drawn only after the completion of clinical trial |