| CTRI Number |
CTRI/2021/09/036428 [Registered on: 10/09/2021] Trial Registered Prospectively |
| Last Modified On: |
15/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of Panchkoladi Avleha and Tamakswasahara Avleha in the management of Bal Tamakaswasa w.s.r. toChildhood Asthma - A comparartive clinical study |
|
Scientific Title of Study
|
Comparative Clinical Study to evaluate the effect of Panchakoladi Avleha and Tamakswasahara Avleha in the management of Bal Tamakaswasa w.s.r. to Childhood Asthma |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vinod Kumar |
| Designation |
Reader, Kaumarbhritya |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola Distt. Kangra, H.P. |
| Address |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola Distt. Kangra, H.P.
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418037777 |
| Fax |
|
| Email |
drvinod60@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinod Kumar |
| Designation |
Reader, Kaumarbhritya |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola Distt. Kangra, H.P. |
| Address |
Room no. 802 Dept. of Kaumarbhritya Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola Distt. Kangra, H.P.
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418037777 |
| Fax |
|
| Email |
drvinod60@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Pathania |
| Designation |
2nd Year Student, Kaumarbhritya |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola Distt. Kangra, H.P. |
| Address |
Room no. 802 Dept. of Kaumarbhritya Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola Distt. Kangra, H.P.
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9459953122 |
| Fax |
|
| Email |
deepakpathania2003@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Pharmacy, RGGPG Ayurvedic College and Hospital Paprola, Kangra, H.P. Research Institute in ISM Jogindernagar(H.P.) M/s Shashi Pal Gourav Kumar Khoo Bazar Paprola Teh. Baijnath Distt. Kangra (H.P.)
|
|
|
Primary Sponsor
|
| Name |
Principal |
| Address |
RGGPG Ayurvedic College and Hospital Paprola, Kangra, H.P. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| HOD Department of Kaumarbhritya |
RGGPG Ayurvedic College and Hospital Paprola, Kangra, H.P. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vinod Kumar |
RGGPG Ayurvedic College and Hospital, Paprola, Kangra. |
OPD and IPD of Department of Kaumarbhritya
Kangra
HIMACHAL PRADESH |
9418037777
drvinod60@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee RGGPG Ayurvedic College and Hospital, Paprola, Kangra. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J45||Asthma. Ayurveda Condition: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Panchkoladi Avleha, Reference: Astang Sangrah, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 4(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: Dose will be fixed according to Acharya Yoga Ratnakar (Age wise) 4g dose is mentioned above for age group 12-16 yrs | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Tamakswasahara Avleha, Reference: Kasyapa Khila Sthana, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 4(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: Dose will be fixed according to Acharya Yoga Ratnakar (Age wise) 4g dose is mentioned above for age group 12-16 yrs |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1)Parents/guardians of the children willing to participate in research trial.
2) Only mild to moderate stable patients of childhood asthma will be included.
3) Positive test of reversibility in oxygen saturation, PEFR,FEV1:FVC in children.
4) Age group between 5 to 16 years.
|
|
| ExclusionCriteria |
| Details |
1)Parents/parents of the patients not willing to participate in research trial.
2) Patients having severe childhood asthma/ Status asthamaticus condition.
3) Patient presenting systemic illness like pneumonitis, pleural effusion, pulmonary TB etc.
4) Children with congenital anomalies.
5) Patient with PEFR<50% & FEV1<50%.
6) Patient on prolonged (>6week) medication with corticosteroids, bronchodialators, mast cell stablizers,anticholinergics etc. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fulfillment of objective and subjective criteria. |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| General feeling of well-being |
28 days |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
13/09/2021 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Research Report will be soon published after the completion of trial. 40 patients fulfilling the inclusion and exclusion criteria will be randomly selected from the OPD and IPD of Department of Kaumarbhritya, RGGPG Ayurvedic College and Hospital, Paprola. Patients will be divided randomly into 2 groups; Group 1 and Group 2 each with 20 patients. Group 1 will be given Panchkoladi Avleha orally while group 2 will be given Tamakswasahara Avleha orally. Result will be assessed on the basis of subjective and objective assessment criterias. |