| CTRI Number |
CTRI/2025/03/081519 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate the effect of Yavaksharadi Vati and Apamargadi Taila Nasya in the management of Kanthshalook w.s.r. to Adenoid Hypertrophy. |
|
Scientific Title of Study
|
A clinical study to evaluate the effect of Yavaksharadi Vati and Apamargadi Taila Nasya in the management of Kanthshalook w.s.r. to Adenoid Hypertrophy. |
| 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 and Hospital, Paprola |
| Address |
PG Department of Shalakya Tantra, Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital, Paprola, Distt. Kangra, H.P.
176115
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 and Hospital, Paprola |
| Address |
PG Department of Shalakya Tantra, Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital, Paprola, Distt. Kangra, H.P.
176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418017568 |
| Fax |
|
| Email |
bhardwajvijayant@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ruchika |
| Designation |
PG scholar |
| Affiliation |
Rajiv Gandhi Govrnment Post Graduate Ayurvedic College and Hospital |
| Address |
PG Department of Shalakya Tantra, Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital, Paprola, Distt. Kangra, H.P. 176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
7018943439 |
| Fax |
|
| Email |
ruchic632@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Pharmacy, Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola, Distt. Kangra,H.P.
176115 |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital |
| Address |
Rajiv Gandhi Government Post Graduate Ayurvedic College and Hospital, Paprola, Distt. Kangra,H.P.
176115 |
| 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 Govt Post Graduate Ayurvedic College and Hospital, Paprola |
OPD No. 201, Rajiv Gandhi Govt 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 Govt. Post Graduate Ayurvedic College and Hospital, Paprola, Distt. Kangra, H.P. 176115, India Kangra HIMACHAL PRADESH 176115 India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J352||Hypertrophy of adenoids. Ayurveda Condition: KANTHASALUKAH/TUNDIKERI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yavaksharadi Vati, Reference: Chakradutta 56/83, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Sukhoshna Jala), Additional Information: Dose-4mg/kg body weight for Children | | 2 | Comparator Arm | Procedure | - | Pratimarsh Nasya | (Procedure Reference: Sharndhar Samhita, Procedure details: 2 drops in each nostril QID for 15 days)
(1) Medicine Name: Apamargadi Taila, Reference: Astang Hriday, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: qid, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients Willing for trials.
Patients will be selected on the basis of sign and symptoms of Kanthshalook w.s.r. Adenoid Hypertrophy.
Patient of either gender above 5 years of age will be selected. |
|
| ExclusionCriteria |
| Details |
Patients suffering from metabolic disorders like Diabetes Mellitus.
Immuno compromised patients.
Congenital deformity.
Patients not willing to be registered for the trials. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in sign and symptoms of Adenoids hypertrophy in patient |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of Yavaksharadi Vati and Apamargadi Taila Nasya in the management of Kanthshalook w.s.r. to Adenoid Hypertrophy. |
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)
|
15/04/2025 |
| 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 Yet Recruiting |
| 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. Patient will be registered from OPD /IPD of RGGPG Ayurvedic College and Hospital. 3 group of 30 patients will be registered and assessed to evaluate the effect of Yavaksharadi Vati and Apamargadi Taila Nasya in the management of kanthshalook w.s.r to Adenoid Hypertrophy. |