| CTRI Number |
CTRI/2017/03/008050 [Registered on: 08/03/2017] Trial Registered Prospectively |
| Last Modified On: |
08/03/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Kumarabharana Rasa in children with chronic tonsillitis |
|
Scientific Title of Study
|
An open labelled multicentric prospective clinical study to assess the effectiveness of Kumarabharana Rasa in recurrent upper respiratory tract infections with special reference to chronic tonsillitis 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 Prasanna Narasimha Rao |
| Designation |
Professor and Principal |
| Affiliation |
SDM College of Ayurveda and Hospital |
| Address |
SDM College of Ayurveda and Hospital,
BM Road,
Thanniruhalla,
Hassan 573201,
Karnataka,
India
Hassan
KARNATAKA
573201
India |
| Phone |
9448064277 |
| Fax |
08172256464 |
| Email |
profpnrao@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Raj GR |
| Designation |
Assistant Professor |
| Affiliation |
SDM College of Ayurveda and Hospital |
| Address |
Assistant Professor,
Department of Kaumarabhritya,
SDM College of Ayurveda and Hospital,
BM Road,
Thanniruhalla,
Hassan 573201,
Karnataka,
India
Hassan
KARNATAKA
573201
India |
| Phone |
9886292826 |
| Fax |
08172256464 |
| Email |
drdrarunraj26@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shailaja U |
| Designation |
Professor and Head |
| Affiliation |
SDM College of Ayurveda and Hospital |
| Address |
Department of Kaumarabhritya, SDM College of Ayurveda and Hospital,
BM Road,
Thanniruhalla,
Hassan 573201,
Karnataka,
India
Hassan
KARNATAKA
573201
India |
| Phone |
9448816433 |
| Fax |
08172256464 |
| Email |
rao.shaila@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi University of Health Sciences, Karnataka, Bengaluru |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Shri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,
BM Road, Thanniruhalla,
Hassan – 573201, Karnataka, India
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sri Sri College of Ayurvedic Science and Research |
Sri Sri College of Ayurvedic Science and Research, Udayapura, Bengaluru - 560082. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shailaja U |
SDM College of Ayurveda and Hospital |
OPD No.2, Department of Kaumarabhritya
Hassan
KARNATAKA |
9448816433
08172256464
rao.shaila@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Chronic tonsillitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kumarabharana Rasa |
Kumarabharana Rasa tablet of 500 mg, before food in the morning once a day mixed with honey orally for a period of 60 days on empty stomach. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Children of both genders between 5-10 years of age, who were suffering from repeated attacks of tonsillitis (chronic) in past year. Those participants whose parents are ready to sign the consent form and allow their children to participate in the clinical trial will be included. |
|
| ExclusionCriteria |
| Details |
Patients with acute tonsillitis, peritonsillar abscess, tonsillar cyst, tonsillolith or with any other systemic disorders. Also the patients who have taken systemic steroids and/or antibiotics in the past four weeks. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Enlargement of tonsils (Kathinashotha), Hyperemia (Ragatwa), Dysphagia (Galoparodha), Halitosis (Mukhadaurgandhya) and Enlargement of lymph nodes (Lasikagranthi Vriddhi). |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in Haemoglobin%, Total
leukocyte count, Differential leukocyte count, Erythrocyte sedimentation rate and
Absolute Eosinophil Count.
|
60 days |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
02/04/2018 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
No publications yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is an open labelled multicentric prospective clinical study to assess the effectiveness of Kumarabharana Rasa in recurrent upper respiratory tract infections with special reference to chronic tonsillitis in children. The subjects were given tablets of 500 mg, before food in the morning once a day mixed with honey orally for a period of 60 days on empty stomach. The primary outcome measures will be Enlargement of tonsils (Kathinashotha), Hyperemia (Ragatwa), Dysphagia (Galoparodha), Halitosis (Mukhadaurgandhya) and Enlargement of lymph nodes (Lasikagranthi Vriddhi). The changes in Haemoglobin%, Total leukocyte count, Differential leukocyte count, Erythrocyte sedimentation rate and Absolute Eosinophil Count will be noted. |