| CTRI Number |
CTRI/2015/11/006340 [Registered on: 03/11/2015] Trial Registered Retrospectively |
| Last Modified On: |
29/10/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
A clinical Study on Bronchial Asthma in children |
|
Scientific Title of Study
|
A clinical study on the management of Tamaka Shwasa with special reference to Bronchial Asthma in children with Shwasahara Dashemani |
| Trial Acronym |
TSSD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NEHA R PATEL |
| Designation |
MD Ayu 2 year |
| Affiliation |
INSTITUTE FOR POSTGRADUATE TEACHING and RESEARCH IN AYURVEDA |
| Address |
ROOM NO 114 PG GIRLS HOSTEL
GARGI BHAVAN GUJARAT AYURVED UNIVERSITY JAMANGAR 361 008
GUJARAT INDIA
DEPARTMENT OF KAUMARABHRITYA
IPGT and RA GUJARAT AYURVED UNIVERSITY JAMNAGAR 361 008
Jamnagar
GUJARAT
361008
India |
| Phone |
9429386893 |
| Fax |
|
| Email |
neharpatelkb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RAJAGOPALA S |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
INSTITUTE FOR POSTGRADUATE TEACHING and RESEARCH IN AYURVEDA |
| Address |
A 202 SHIVAM PLAZA 1
10 PATEL COLONY MAIN ROAD
JAMNAGAR 361008
DEPARTMENT OF KAUMARABHRITYA
IPGT and RA GUJARAT AYURVED UNIVERSITY JAMNAGAR 361 008
Jamnagar
GUJARAT
361008
India |
| Phone |
9426953318 |
| Fax |
|
| Email |
drrajagopala@ayurveduniversity.com |
|
Details of Contact Person
Public Query
|
| Name |
PROF KALPANA S PATEL |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
INSTITUTE FOR POSTGRADUATE TEACHING and RESEARCH IN AYURVEDA |
| Address |
PROFESSOR AND HEAD
DEPARTMENT OF KAUMARABHRITYA
IPGT and RA GUJARAT AYURVED UNIVERSITY JAMNAGAR 361 008
DEPARTMENT OF KAUMARABHRITYA
IPGT and RA GUJARAT AYURVED UNIVERSITY JAMNAGAR 361 008
Jamnagar
GUJARAT
361008
India |
| Phone |
9427574566 |
| Fax |
|
| Email |
drkspatel2007@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DIRECTOR |
| Address |
INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA GUJARAT AYURVED UNIVERSITY JAMNAGAR 361008 |
| 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 |
| Neha R Patel |
IPGTRA GAU JAMNAGAR |
PG hospital IPGTRA GAU JAMNAGAR 361008
Jamnagar
GUJARAT |
9429386893
neharpatel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee IPGT RA GAU Jamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Diseased having signs and symptoms of bronchial asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Shwasahara Dashemani churna with single bhavana of the decoction of Shwasahara Dashemani drugs
Reference Charaka Samhita Sutra sthana 4 chapter shlok no 37 |
Churna of eight herbs 1 part namely Pushkaramoola Inula racemosa
Aquru Aqueleria agalocha
Amlavetasa Garcenia pedunculata
Hingu Ferula narthex
Ela Elettaria cardamomum
Surasa Ocimum sanctum
Tamalaki Phyllanthus niruri
Jeevanti Leptadenia reticulata while Shathi Hedychium spicatum two parts
This churna is triturated one time with the decoction or kashaya of the same nine above mentioned drugs in quantity sufficient required for bhavana
|
| Intervention |
Shwasahara Dashemani churna with the sapta bhavana with the decoction of same Shwasahara dashemani drugs
Reference Charaka Samhita Sutra sthana 4 chapter shlok no 37 |
Churna of eight herbs 1 part namely
Pushkaramoola Inula racemosa
Aguru Aqueliria agalocha
Amlavetasa Garcenia pedunculata
Hingu Ferula narthex
Ela Elettaria cardamomum
Surasa Ocimum sanctum
Tamalaki Phyllanthus niruri
Jeevanti Leptadenia reticulata
While
Shathi Hedychium spicatum two parts
This churna is triturated seven times with the decoction or kashaya of the same nine above mentioned drugs in quantity sufficient required for bhavana |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Patients of 2 to 12 years of age of either sex
Diagnosed cases of Tamaka Shwasa Bronchial Asthma with at least 2 episodes of asthma symptoms during the previous year
Patients on other drug therapy will be included only after completion of wash out period of 3 weeks
Patients or Parents or legal guardians willing to give written informed consent or assent
|
|
| ExclusionCriteria |
| Details |
Children of age below 2 years and above the 12 years
Evidence of active concomitants pulmonary disease other than asthma
Evidence of requirement of intubations for asthma or had been hospitalized for asthma within one month before. Had unresolved sinus disease or an unresolved upper or lower respiratory tract infection within 2 weeks
Patients on active corticosteroid therapy or more than 4 short courses of oral corticosteroids within the year preceding the screening visit or any oral corticosteroids in the preceding 4 weeks
Use of Astemizole Nedocromil Cromolyn long acting beta agonists Ketotifen or Theophylline within 2 weeks before
Concomitant severe decompensated 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
|
Participant and Investigator Blinded |
|
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 attacks of breathlessness
To increase the immunity against allergens |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
12/03/2015 |
| 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) |
Open to Recruitment |
|
Publication Details
|
No any related publications |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Present clinical trail is randomized double blind study on Tamaka Shwasa wsr to bronchial asthma in children of either sex between 2 to 12 years of age. Study will evaluate the role of Shwasahara Dashemani a combination of ten herbs from Charaka Samhita. Intervention drug is Shwasaha Dashemani churna prepared with seven bhavana of Kashaya of the same drug of Shwasahara Dashemani while comparator agent is Shwasahara Dashemani churna prepared with single bhavana with the kashaya of drugs of Shwasahara Dashemani Study is going to be conducted with primary aim to relieve the symptoms of childhood asthma
Till date 30 patients are registered in clinical trail As trail is in progress final conclusion or remarks can be drawn only after the completion of clinical trail |