| CTRI Number |
CTRI/2026/03/105779 [Registered on: 10/03/2026] Trial Registered Prospectively |
| Last Modified On: |
09/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to check if an Ayurvedic mouth-dissolving tablet helps relieve cough, sore throat, hoarseness of voice and bad breath |
|
Scientific Title of Study
|
An open-label, single-arm clinical study to assess the efficacy and safety of a Mouth-Dissolving Ayurvedic Tablet (MDAT) for symptomatic relief of acute cough, sore throat, hoarseness of voice and bad breath. |
| 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 R M Muthiah MBBS MD |
| Designation |
Critical Care Physician |
| Affiliation |
Oxymed Hospital Medical & Healthcare Center, |
| Address |
Oxymed Hospital Medical & Healthcare Center,
No 14/1,2nd street,
3rd Main Road,
Nandanam, Chennai
Chennai
TAMIL NADU
600035
India |
| Phone |
9994399111 |
| Fax |
|
| Email |
muthsmail@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Sakthi Balan MBBS MD |
| Designation |
Consultant |
| Affiliation |
KI3 PRIVATE LIMITED |
| Address |
Ki3 Office, Regus Centre Level 2, Altius Block No 1, SIDCO Industrial Estate, Chennai
No 5 3, Dr Jayalakshmi Street, Radha Nagar, Chrompet, Chennai
Chennai
TAMIL NADU
600032
India
Chennai
TAMIL NADU
600032
India |
| Phone |
9443627722 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayathri Sivakumar |
| Designation |
Director |
| Affiliation |
KI3 PRIVATE LIMITED |
| Address |
Room no 1, Clinical trial department, No 5 3, Dr Jayalakshmi Street, Radha Nagar, Chrompet, Chennai TAMIL NADU India
Chennai
TAMIL NADU
600 044
India |
| Phone |
09003109416 |
| Fax |
|
| Email |
drgayathri@ki3services.com |
|
|
Source of Monetary or Material Support
|
| Vasu Health Care Pvt. Ltd, A2/624-625/2, G.I.D.C., Makarpura, Vadodara 390010 (Gujarat) India |
|
|
Primary Sponsor
|
| Name |
Vasu Health Care Pvt. Ltd |
| Address |
A2/624-625/2, G.I.D.C., Makarpura, Vadodara 390010 (Gujarat) India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 R M Muthiah MBBS MD |
Oxymed Hospital Medical & Healthcare Center |
No 14/1,2nd street,
3rd Main Road,
Nandanam,
Chennai
TAMIL NADU |
9994399111
muthsmail@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Oxymed ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J069||Acute upper respiratory infection,unspecified. Ayurveda Condition: KASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Mouth Dissolving Ayurvedic Tablet, Reference: NA, Route: Oral, Dosage Form: Lozenges, Dose: 50(mg), Frequency: sos, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and Female age between 12 and 65 years.
2. Acute or subacute cough with sore throat or hoarseness or bad breath of less than or equal to 14 days duration (onset less than or equal to 14 days).
3. Baseline cough VAS greater than or equal to 3 out of 10.
4. Able and willing to comply with study procedures and give written informed consent.
5. Women of childbearing potential using reliable contraception, during the study period.
|
|
| ExclusionCriteria |
| Details |
1. Known allergy to any ingredient in the tablet.
2. Severe upper (pharyngitis) or lower respiratory infection (e.g., pneumonia), clinically suspected bacterial throat infection requiring antibiotics, or any condition requiring immediate hospitalization.
3. Chronic severe respiratory disease (e.g., COPD GOLD stage II–IV, uncontrolled asthma).
4. Use of oral or inhaled antibiotics or systemic corticosteroids in past 7 days.
5. Use of other cough or antitussive or antiseptic throat lozenges within 12 hours before baseline (short washout may be requested).
6. Pregnant or breastfeeding women.
7. Significant hepatic, renal, cardiac disease or immunosuppression.
8. Current smoker of grater then 20 cigarettes per day (optional exclusion), or any other condition in investigator’s opinion that precludes participation.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in cough VAS |
baseline to day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean change in sore throat, throat comfort and ease of swallowing by VAS
Mean change in VHI-10
Mean change in organoleptic score and Halimeter scores for bad breath
Mean time to meaningful cough relief.
Proportion of participants with greater than or equal 50% reduction in cough VAS by Day 3 and Day 7.
For safety assessment screening lab parameters will be repeated
Number and severity of AEs.
|
baseline to day 7 |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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 3 |
|
Date of First Enrollment (India)
|
25/03/2026 |
| 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="0"
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
|
This Phase 3, open-label, single-arm interventional clinical study is designed to evaluate the efficacy, safety, and tolerability of a Mouth-Dissolving Ayurvedic Tablet (MDAT) in participants with acute or subacute cough (less than or equal 14 days duration) associated with sore throat, hoarseness of voice, and/or bad breath.
A total of 66 evaluable male and female participants aged 12–65 years with baseline cough Visual Analogue Scale (VAS) greater then or equal 3 will be enrolled. Participants will receive one MDAT tablet every 2 hours, up to a maximum of 6 tablets per day, for 7 consecutive days. The total duration of participation will be 14 days, including a 7-day treatment period and follow-up until Day 14.
The primary endpoint is the mean change in cough severity (VAS) from baseline to Day 7 (with interim assessment at Day 3). Secondary endpoints include mean change in sore throat VAS, Voice Handicap Index-10 (VHI-10), organoleptic score and Halimeter assessment for halitosis, time to meaningful cough relief, and proportion of participants achieving greater then or equal 50% reduction in cough VAS by Day 3 and Day 7. Safety will be assessed through monitoring of adverse events and laboratory parameters (CBC, RFT, LFT). |