| CTRI Number |
CTRI/2024/01/061247 [Registered on: 09/01/2024] Trial Registered Prospectively |
| Last Modified On: |
15/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study for safety of Betadine Throat Spray with Standard care of therapy |
|
Scientific Title of Study
|
A Phase-III multi centre, randomized, parallel, double blind, placebo control, clinical study to determine the efficacy and safety of Betadine PVPI-0.45 % weight per volume throat spray, applied along with standard of care therapy in patients suffering from Tonsillitis and Pharyngitis (throat infections). |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT-CE-TS-2022 Version 1.0 dated 19 Sept 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shailesh Kothalkar |
| Designation |
Director and Chief Consulting Surgeon |
| Affiliation |
Kothalkar Clinic |
| Address |
Kothalkar Clinic, 40 Mohta Science college, Sakkardara chowk Nagpur -09
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9822220920 |
| Fax |
|
| Email |
kothalkar@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailesh Kothalkar |
| Designation |
Director and Chief Consulting Surgeon |
| Affiliation |
Kothalkar Clinic |
| Address |
Kothalkar Clinic, 40 Mohta Science college, Sakkardara chowk Nagpur -09
MAHARASHTRA
440024
India |
| Phone |
9822220920 |
| Fax |
|
| Email |
kothalkar@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini Kumar |
| Designation |
Chief Executive Officer |
| Affiliation |
CliniExperts Research Services |
| Address |
Plot No. 5, Unit no. 325, City Centre Mall, Sector 12, Dwarka
West
DELHI
110075
India |
| Phone |
9999219448 |
| Fax |
|
| Email |
ashwini.kumar@cliniexpertsresearch.com |
|
|
Source of Monetary or Material Support
|
| G.S. Pharmbutor Private Limited Head Office: 415, Modi Tower, 98, Nehru Place, New
Delhi-110019 |
|
|
Primary Sponsor
|
| Name |
GS Pharmbutor Private Limited |
| Address |
G.S. Pharmbutor Private Limited, Plot no 58, 59 66 & 67 Sector 3, Integrated Industrial Estate, (IIE), Pantnagar- 263146, Uttrakhand |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Idranil Pal |
College of Medicine and JNM Hospital |
Clinical Trial Room, 1st Floor, OPD Building, College of Medicine and Jawaharlal Nehru Memorial Hospital, Block-A, Kalyani Nadia, West Bengal-741235
Nadia
WEST BENGAL |
9824789534
thisisindranil@yahoo.co.in |
| Dr Gondela Hari Krishna |
Department of ENT, Government-ENT Hospital |
Department of ENT, Government-ENT Hospital, Visakhapatnam, Andhra Pradesh - 530017
Visakhapatnam
ANDHRA PRADESH |
7382006743
drgharikrishnaresearch@gmail.com |
| Dr Shailesh Kothalkar |
Kothalkar Hospital |
Research Room, Ground Floor, Kothalkar Clinic, Plot no. 40, Opposite Mohta Science College, Reshimbag, Sakkardara Square, Nagpur- 440009
Nagpur
MAHARASHTRA |
9822220920
kothalkar@hotmail.com |
| Dr Vivek V Harkare |
NKP Salve Institute of Medical Sciences and Research Center And Lata Mangeshkar Hospital |
NKP Salve Institute of Medical Sciences and Research Center And Lata Mangeshkar Hospital, Hingna Road, Department of ENT, Room no. 2
Nagpur
MAHARASHTRA |
9422105174
viv_harkare@rediffmail.com |
| Dr Surendra Singh Baghel |
Pushpanjali Hospital and Research Centre |
Clinical Research Room, First Floor, Annexure Building, Block-C, Pushpanjali Hospital & Research Centre Pvt Ltd, Pushpanjali Palace Delhi Gate Road, Agra, Uttar Pradesh-282002
Agra
UTTAR PRADESH |
8386904675
surendrabaghel3@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Gullurkar Hospital Ethics Committee |
Approved |
| I. E. C., College of Medicine and JNM Hospital |
Approved |
| IEC King George hospital |
Approved |
| Institutional Ethics Committee NKP Salve |
Approved |
| Pushpanjali Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J039||Acute tonsillitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Betadine PVPI-0.45 percentage weight per volume Throat Spray
|
Dose-0.45 percentage weight per volume Throat Spray
Frequency- One or two spray, 3-4 times a day
Duration- 5 days |
| Comparator Agent |
Placebo Throat Spray |
Dose-Placebo Throat spray
Frequency- One or two spray, 3-4 times a day
Duration- 5 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Males and females aged 18 -65 years older at the time of screening.
2. Presence of at least two sign and symptoms at the time of screening e.g., sore throat, pharynx discomfort, swelling, redness, pain in swallowing, hoarseness of voice, foreign object sensation in throat.
3. Participants who will be able to provide written informed consent prior to the performance of any study specific procedures.
4. Female participants of child-bearing potential with negative urine pregnancy test at the time of screening.
5. Participants who are willing and able to comply with all study assessments and adhere to the protocol schedule
|
|
| ExclusionCriteria |
| Details |
1.Known cases of Thyroid dysfunction as per medical history taken by Investigator at the time of screening.
2.Patients undergone or planning to go for thyroidectomy.
3.If the patient has goiter, thyroid nodules, or other thyroid diseases.
4.Known hypersensitivity to any ingredient of the study drug.
5.Severe sepsis
6.Advanced Tonsilo Pharyngeal disease or infection
7.Pregnant and Lactating women
8.Subjects who take any medication likely to interfere with the study.
9.Subjects who are unwilling or unable to give written inform consent.
10.Patients involved in clinical trials and taken Investigational drugs within 30 days of enrolment. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the changes in Tonsillopharyngitis sign and symptoms –
[Time frame: Baseline to EOT(Day6)]
Efficacy will be analyzed with the help of a 5-point Likert scale on the following sign and symptoms i.e., Sore throat, pharynx discomfort, swelling, redness, pain in swallowing, hoarseness of voice, foreign object sensation in throat.
5-point Likert scale includes 0-Absence of symptoms
1-Mild symptoms
2-Moderate symptoms
3-Severe symptoms
4-Very severe |
upto day 6 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the average time taken to reduce or remission of the main Tonsillopharyngitis sign and symptoms of 5 days treatment regimen.
Time taken in 50 percentage reduction in the main complaints i.e., sore throat, pharynx discomfort, swelling, redness, pain in swallowing, hoarseness of voice, foreign object sensation in throat
[Time frame: Baseline to EOT (Day 6)]
2.No statistically significant difference in Thyroid Function Test (TFT) after 5 days of completion of therapy. TFT to be done on day 01 and 06 in the treated population compared to placebo.
3.Quality of life will be evaluated based on STQoL (Sore Throat Quality of Life) questionnaire.
4.Adverse events (AEs) monitoring during the study period.
5.Oropharyngeal soft tissue irritation or tolerability of IP assessment
6.Physical examination & vital signs. |
upto Day 6 |
|
|
Target Sample Size
|
Total Sample Size="192"
Sample Size from India="192"
Final Enrollment numbers achieved (Total)= "192"
Final Enrollment numbers achieved (India)="192" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
18/01/2024 |
| Date of Study Completion (India) |
14/04/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Acute pharyngitis and tonsillitis are common
respiratory diseases for which
seek medical care. Their main clinical manifestation is sore throat
which interferes with patients’ quality
of life.
Numerous drugs as
well as traditional remedies are offered to the patient suffering from
pharyngitis and tonsilitis, but all
deliver little more than symptomatic relief. Antibiotics are prescribed to
limit secondary bacterial infections, and last resort
measures for severe infections include intracellular virus inhibitors, but those are not very effective to
regularly treat throat infections. The frequent use of antibiotics may lead to resistant of it and it may not be as
effective as it should be. The subsequent development of bacterial resistance
e.g., increasing van-comycin-resistant enterococci (VRE) and
methicillin-resistant Staphylococcus aureus (MRSA).The investigational product is believed to have a very fast action to the oral infection (viral, bacterial, fungal
origin) and less frequent requirement
of antibiotic treatment. The spray dosage form of PVPI-0.45% w/v may help to kill the bacterial, viral
or fungal infection of the oral cavity in a very fast way because medicinal compounds
are directly approaching to the affected
area without or less systemic
absorption |