| CTRI Number |
CTRI/2021/11/037958 [Registered on: 11/11/2021] Trial Registered Prospectively |
| Last Modified On: |
30/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study of Vyaghryadi Churna (Powder) in the treatment of Tamaka Shwasa (Bronchial Asthma) |
|
Scientific Title of Study
|
A SINGLE ARM CLINICAL STUDY TO EVALUATE THE EFFICACY OF VYAGHRYADI CHURNA IN THE MANAGEMENT OF TAMAKA SHWASA IN CHILDREN |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR NILAM MAHADEV SAMBRE |
| Designation |
M D SCHOLAR KAUMARBHRITYA |
| Affiliation |
DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 18 |
| Address |
OPD NO 1 AND IPD BALROG DEPARTMENT DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 18 SANT TUKARAM NAGAR
Pune
MAHARASHTRA
411018
India |
| Phone |
8605382856 |
| Fax |
|
| Email |
nilamsambre@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RAVINDRA RAMCHANDRA RAJPAL |
| Designation |
ASSO-PROFESSOR KAUMARBHRITYA DEPARTMENT |
| Affiliation |
DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 18 |
| Address |
OPD NO 1 AND IPD BALROG DEPARTMENT DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 18
Pune
MAHARASHTRA
411018
India |
| Phone |
9922037201 |
| Fax |
|
| Email |
ravirajpal24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RAVINDRA RAMCHANDRA RAJPAL |
| Designation |
ASSO-PROFESSOR KAUMARBHRITYA DEPARTMENT |
| Affiliation |
DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 18 |
| Address |
OPD NO 1 AND IPD BALROG DEPARTMENT DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 18
Pune
MAHARASHTRA
411018
India |
| Phone |
9922037201 |
| Fax |
|
| Email |
ravirajpal24@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 18 SANT TUKARAM NAGAR DEEMED TO BE UNIVERSITY |
|
|
Primary Sponsor
|
| Name |
DR NILAM MAHADEV SAMBRE |
| Address |
OPD NO 1 KAUMARBHRITYA DEPARTMENT DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 18 SANT TUKARAM NAGAR |
| Type of Sponsor |
Other [SELF] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR NILAM MAHADEV SAMBRE |
DR D Y PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE 18 |
OPD NO 1 AND IPD BALROG
Pune
MAHARASHTRA |
8605382856
nilamsambre@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J459||Other and unspecified asthma. Ayurveda Condition: TAMAKASVASAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: VYAGHRYADI CHURNA, Reference: SHARANGADHAR SAMHITA MADHYAMKHANDA CHURNA PRAKARAN SHLOK 147, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Muhurmuhu, Duration: 15 Days, anupAna/sahapAna: Yes(details: MADHU (HONEY)), Additional Information: POWDER OF KANTAKARI AAMALAKI AND JEERAK ADVISED TO TAKE ALONG WITH HONEY TO BE TAKEN THRICE A DAY FOR 15 DAYS
FOLLOW UP WILL BE DONE ON 7TH AND 15 TH DAY
DOSE WILL BE CALCULATED ACCORDING TO AGE AND WEIGHT |
|
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Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1)CHILDREN WITH SYMPTOMS OF TAMAKA SHWASA AS MENTIONED BY CHARAK ARE AS FOLLOWS
SHWASAKRUCHHRATA(DYSPNEA)
KASA(COUGH)
GHUR GHUR SHABDA(WHEEZING)
KASHTEN SHLESHMA MOKSHA(DIFFICULTY IN EXPECTORANT)
PEENAS
2)CHILDREN ARE OF AGE GROUP 1YEAR TO 12 YEARS
3)CHILDREN WHO HAVE A HISTORY OF URTI 3-4 TIMES PER YEAR AND ALLERGIC RHINITIS AND ALSO HISTORY OF USING NEBULIZATION FREQUENTLY
4)CHILDREN WILL BE SELECTED IRRESPECTIVE OF SEX SOCIO ECONOMIC STATUS
5)CHILDRENS WHOSE PARENTS ARE READY TO PARTICIPATE IN THE CLINICAL TRIAL BY GIVING INFORM WRITTEN CONSENT |
|
| ExclusionCriteria |
| Details |
1)PATIENTS HAVING LIFE THREATENING ILLNESS AND WHO ARE BED RIDDEN
2)PATIENTS HAVING ANY CONGEITAL RESPIRATORY AND GIT ABNORMALITY
3)PATIENTS WHO REQUIRE SURGICAL MANAGEMENT
4)PATIENTS WITH THE HISTORY OF PULMONARY TUBERCULOSIS PLEURAL EFFUSION EMPHYSEMA BRONCHIAL CARCINOMA STATUS ASTHMATICUS
5)PATIENTS HAVING OTHER SYSTEMIC MAJOR ILLNESS SUCH AS AIDS CARDIAC DISEASE RENAL FAILURE
6)PATIENTS WITH SEVERE ASTHMATICUS CONDITION WHO NEEDS EMERGENCY TREATMENT
7)PATIENTS HAVING DISEASE COVID19 TUBERCULOSIS |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO EVALUATE THE IMPROVEMENT IN SHWASAKRUCHHRATA AND GHURGHURAK SHABDA AFTER TAKING VYAGHRYADI CHURNA |
Vyaghryadi Churna with Honey will be given on 0th and 7th day for thrice a day
Follow-ups will be on 7th and 15th day
Total duration of study will be 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
TO STUDY THE CLASSICAL TEXTUAL REVIEW OF TAMAKA SHWASA IN CHILDREN
TO ASSESS THE IMPROVEMENT IN RESPIRATORY RATE ACCORDING TO AGE OF CHILDREN |
Vyaghryadi Churna with Honey will be given on 0th and 7th day for thrice a day
Follow-ups will be on 7th and 15th day
Total duration of study will be 15 days |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/01/2022 |
| 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 Yet Recruiting |
| 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)?
Response - NO
|
|
Brief Summary
|
This is a single arm clinical study in which Medicine Vyaghryadi Churna will be provided to 30 patients showing classical signs and symptoms of Tamaka shwasa (Bronchial Asthma) for relieving symptoms. The age group taken for the study trial will be between 1years and upto 12 years. Vyaghryadi Churna with Honey will be given on 0th and 7th day for thrice a day .Dose will be calculated by age formula . Follow-up will be on 7th and 15th day and total duration of the case study will be 15 days. |