| CTRI Number |
CTRI/2024/05/066714 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
02/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
TO STUDY EFFECT OF DURALABHADI LEHA IN TAMAKASHWAS(CHILDHOOD ASTHMA) IN CHILDREN |
|
Scientific Title of Study
|
A single arm clinical study to evaluate the efficacy of duralabhadi leha in the management of tamakashwas in children. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pranjali Undre |
| Designation |
PG SCHOLAR |
| Affiliation |
DR. D.Y. PATIL COLLEGE OF AYURVED ,PIMPRI PUNE. |
| Address |
OPD No.1 and IPD Kaumarbhritya Bala Roga Department,Dr.D.Y.Patil College
Of Ayurveda and Research Centre,Sant Tukaram Nagar, Pimpri,
Pune
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
7719980540 |
| Fax |
|
| Email |
drpranjaliundre@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Sahebrao Khawale |
| Designation |
Professor And Head of Department |
| Affiliation |
DR. D.Y. PATIL COLLEGE OF AYURVED ,PIMPRI PUNE. |
| Address |
OPD No.1 and IPD Kaumarbhritya Bala Roga Department,Dr.D.Y.Patil College
Of Ayurveda and Research Centre,Sant Tukaram Nagar, Pimpri,
Pune
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9923220055 |
| Fax |
|
| Email |
drdeepak77@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pranjali Undre |
| Designation |
MD Scholar |
| Affiliation |
DR. D.Y. PATIL COLLEGE OF AYURVED ,PIMPRI PUNE. |
| Address |
OPD No.1 and IPD Kaumarbhritya Bala Roga Department,Dr.D.Y.Patil College
Of Ayurveda and Research Centre,Sant Tukaram Nagar, Pimpri,
Pune
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
7719980540 |
| Fax |
|
| Email |
drpranjaliundre@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.D.Y.Patil College Of Ayurveda and Research Centre,Sant Tukaram Nagar, Pimpri, Pune,
Maharashtra 411018 |
|
|
Primary Sponsor
|
| Name |
Dr Pranjali Undre |
| Address |
OPD No.1 and IPD Kaumarbhritya Department,Dr.D.Y.Patil College
Of Ayurveda and Research Centre,Sant Tukaram Nagar, Pimpri,
Pune, Maharashtra 411018 |
| Type of Sponsor |
Other [self] |
|
|
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 Pranjali Undre |
Dr.D.Y.Patil College Of Ayurved and Research Centre Pimpri Pune |
OPD No.1 and IPD Kaumarbhritya Bala Roga Department,Dr.D.Y.Patil College Of Ayurved and Research Centre,Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA |
7719980540
drpranjaliundre@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR DYPCA AND RC INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J452||Mild intermittent asthma. Ayurveda Condition: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Duralabhadi Leha, Reference: Yogaratnakar, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: tds, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: Drug dose will be given according to age |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1) Children having symptoms of Tamaka Shwasa as mentioned by Charak :
Shwasakruchhrata (Dyspnea)
Kasa (Cough)
Ghur-Ghurak Shabda (Wheezing)
Kashten Shleshma Moksha (Difficulty in Expectorant)
Peenas
2)Children of age Group 1 year to 12 years.
3) Children who has a family history of asthma with a symptoms of Tamaka
Shwasa.
4)Chidren who are ready to participate in the clinical trial by giving informed
written consent. |
|
| ExclusionCriteria |
| Details |
1)Patients having life threatening illness and who are bed ridden.
2)Patients having any congenital respiratory and GIT abnormality.
3)Patients who require surgical management.
4)Patients with known case of Pulmonary Tuberculosis, Pleural effusion,
Emphysema, Bronchial Carcinoma, Status asthmatics
5)Patients having other systemic major illness like Immunocompromise
diseases, Cardiac Disease, Renal Failure.
6)Patient with severe Asthmatic condition who needs Emergency
treatment. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To decrease breathing difficulty and cough in children |
7 Days study with followup on 4th day and 7th day
(0,4,7 Days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the Adverse effect of Duralabhadi
leha, if any |
7 Days study with followup on 4th day and 7th day
(0,4,7 Days) |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
13/05/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
THIS IS SINGLE ARM CLINICAL STUDY IN WHICH THE MEDICINE DURALABHADI LEHA WILL BE PROVIDED TO 35 PATIENTS SHOWING
SIGN AND SYMPTOMS OF TAMAKSHWAS.THE AGE GROUP TAKEN FOR THE STUDY TRIAL
WILL BE IN BETWEEN 1 YEARS TO 12 YEARS.DURALABHADI LEHA WITH MADHU WILL
BE GIVEN FOR 7 DAY / THRICE A DAY.DOSE WILL BE CALCULATED BY AGE
FORMULA.FOLLOW UP WILL BE DONE ON 4TH AND 7TH DAY AND TOTAL DURATION OF
CASE STUDY WILL BE 7 DAYS.THE FINAL CONCLUSION WILL BE DRAWN ON THE BASIS OF
STATISTICAL METHODS. |