| CTRI Number |
CTRI/2024/08/072114 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
06/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluate the effect of Kshara Gutika and Patoladi Kwatha in the management of Tundikeri w.s.r. to Tonsillitis |
|
Scientific Title of Study
|
A clinical study to evaluate the effect of Kshara Gutika and Patoladi Kwatha in the management of Tundikeri w.s.r. to Tonsillitis |
| 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 Vijayant Bhardwaj |
| Designation |
HOD, Professor PG Department of Shalakya Tantra |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola |
| Address |
Room no. 213, PG Department of Shalakya Tantra, Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola, Distt. Kangra, H.P.
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418017568 |
| Fax |
|
| Email |
bhardwajvijayant@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayant Bhardwaj |
| Designation |
HOD, Professor PG Department of Shalakya Tantra |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola |
| Address |
Room no. 213, PG Department of Shalakya Tantra, Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola, Distt. Kangra, H.P.
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418017568 |
| Fax |
|
| Email |
bhardwajvijayant@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akanksha |
| Designation |
PG Scholar |
| Affiliation |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital,Paprola |
| Address |
PG Department of Shalakya Tantra, Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola, Distt. Kangra, H.P.
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8219032629 |
| Fax |
|
| Email |
akankshapreeti2504@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Pharmacy Rajiv Gandhi Govt. Post Graduate Ayurvedic College and Hospital,Paprola, Kangra, H.P. 176115 India
Baijnath Pharmacy Paprola, Distt. Kangra, H.P. 176115 India
Research Institute in I.S.S.M. Jogindernagar Distt. Mandi, H.P. 175015 India |
|
|
Primary Sponsor
|
| Name |
Charak Pharmacy Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola |
| Address |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola, Distt. Kangra, H.P. 176115 India |
| Type of Sponsor |
Government medical college |
|
|
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 Vijayant Bhardwaj |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola |
OPD No. 201, Department of Shalakya Tantra, Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola, Distt. Kangra,H.P.,176115 India
Kangra
HIMACHAL PRADESH |
9418017568
bhardwajvijayant@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(Human) Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola, H.P. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J039||Acute tonsillitis, unspecified. Ayurveda Condition: TUNDIKERI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kshara Gutika, Reference: Chakradutta 56/4(22-23), Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kshara Gutika, Reference: Chakradutta 56/4(22-23), Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Patoladi Kwatha, Reference: Chakradutta 56/4(36), Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Patoladi Kwatha, Reference: Chakradutta 56/4(36), Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with signs and symptoms
of Tonsillitis.
Patients who consented to participate. |
|
| ExclusionCriteria |
| Details |
Patients with complication of Tonsillitis.
Patients suffering from Malignancy, Diabetic Mellitus, Hypertension.
Immuno-compromised patients.
Congenital deformity.
Patients not willing to be registered for the trial. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in sign and symptoms of Tonsillitis such as congestion,no.of follicles ,dysphagia,sore throat etc |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the effect of Kshara Gutika & Patoladi Kwatha in the improvement of Tonsillitis sign & symptoms such as congestion , size of tonsil,dysphagia,sore throat etc |
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)
|
23/08/2024 |
| 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="0"
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
|
I would like to publish my research work after completion of the trial as soon as possible. Patients will be selected from OPD/IPD of RGGPG Ayurvedic College and Hospital, Paprola. 3 groups with 10 patients each will be registered as assessed to evaluate the effect of Kshara Gutika and Patoladi Kwatha in the management of Tundikeri w.s.r. Tonsillitis. |