| CTRI Number |
CTRI/2025/12/099892 [Registered on: 29/12/2025] Trial Registered Prospectively |
| Last Modified On: |
29/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluate the Efficacy of Kapithashtak Churna in the Management of Tundikeri w.s.r to Tonsillitis |
|
Scientific Title of Study
|
An Open-Label Randomized Controlled Clinical Trial to Evaluate the Efficacy of Kapithashtak Churna 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 Govt. Post Graduate Ayurvedic College & Hospital, Paprola, Kangra, H.P. 176115, India |
| Address |
PG Department of Shalakya Tantra, Rajiv Gandhi Govt. Post Graduate Ayurvedic College & Hospital, Paprola, Kangra
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 Govt. Post Graduate Ayurvedic College & Hospital, Paprola, Kangra, H.P. 176115, India |
| Address |
PG Department of Shalakya Tantra, Rajiv Gandhi Govt. Post Graduate Ayurvedic College & Hospital, Paprola, Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418017568 |
| Fax |
|
| Email |
bhardwajvijayant@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Akanksha Sharma |
| Designation |
PG Scholar |
| Affiliation |
Rajiv Gandhi Govt. Post Graduate Ayurvedic College & Hospital, Paprola, Kangra, H.P. 176115, India |
| Address |
PG Department of Shalakya Tantra, Rajiv Gandhi Govt. Post Graduate Ayurvedic College & Hospital, Paprola, Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8278797044 |
| Fax |
|
| Email |
akankshasharma1612001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Pharmacy Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital, Paprola,
Kangra, H.P. |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital, Paprola |
| Address |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital,
Paprola, Distt. Kangra, H.P. 176115, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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
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 Govt. Post Graduate Ayurvedic College and Hospital, Paprola, Distt. Kangra, H.P. 176115 India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B950||Streptococcus, group A, as the cause of diseases classified elsewhere. Ayurveda Condition: TUNDIKERI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kapithashtak Churna, Reference: Sahastra yoga churna prakrana , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Amoxicillin with clavulanic acid | 625 mg / 12 hourly |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients above 5 years & up to 40 years of age will be selected.
Patients who voluntarily give consent to participate in the study, or in case of children, consent given by parents/ guardians.
Patients exhibiting signs and symptoms of Tundikeri irrespective of gender. |
|
| ExclusionCriteria |
| Details |
Known allergy or hypersensitivity to Amoxicillin & Clavulanic Acid.
Patients with complications of Tonsillitis.
Patients with Malignancies, Diabetes Mellitus & Hypertension.
Immunocompromised patients.
Patients with congenital deformities.
Pregnant & lactating mothers.
Individuals unwilling to participate in the study. |
|
|
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 Kapithashtak Churna 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
|
N/A |
|
Date of First Enrollment (India)
|
18/02/2026 |
| 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. 2 groups with 15 patients each will be registered as assessed to evaluate the effect of Kapithashtak Churna in the management of Tundikeri w.s.r. Tonsillitis. |