| CTRI Number |
CTRI/2026/01/101925 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Study of HCXK-052501 in children with mild to moderate productive cough |
|
Scientific Title of Study
|
An Open Label, Prospective, Multicentric, Clinical Study to Evaluate the Efficacy and Safety of HCXK 052501 in Pediatric Population with Productive Cough |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HWC/MSCD/PP/015/2025, Version 1.0, Dated 31 Dec 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K N Harsha |
| Designation |
Lead Consultant |
| Affiliation |
Sri Laxmi Hospital |
| Address |
OPD No 1, Ground Floor, Doddathogur Rd, Electronic City Phase I, Electronic City, Doddathoguru 560100
Bangalore
KARNATAKA
560100
India |
| Phone |
9900903344 |
| Fax |
|
| Email |
kolalharsha@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Haswathy Srinivasan |
| Designation |
Research Scientist – Medical and Safety |
| Affiliation |
Himalaya Wellness Company |
| Address |
Room No 301, 3rd Floor Medical Services and Clinical Development (R&D), Makali Tumkur Road
Bangalore
KARNATAKA
562162
India |
| Phone |
9632223983 |
| Fax |
|
| Email |
dr.haswathy.s@himalayawellness.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soorya Narayan H |
| Designation |
Manager- Clinical Operations |
| Affiliation |
Himalaya Wellness Company |
| Address |
Room No 301, 3rd Floor Medical Services and Clinical Development (R&D), Makali Tumkur Road
Bangalore
KARNATAKA
562162
India |
| Phone |
8067549919 |
| Fax |
|
| Email |
dr.sooryanarayan.h@himalayawellness.com |
|
|
Source of Monetary or Material Support
|
| Himalaya Wellness Company Room No 301, 3rd Floor Medical Services and Clinical Development (R&D) Makali Tumkur Road, Bangalore Karnataka, 562162 India. |
|
|
Primary Sponsor
|
| Name |
Himalaya Wellness Company |
| Address |
Himalaya Wellness Company Room No 301, 3rd Floor Medical Services and Clinical Development (R&D) Makali Tumkur Road, Bangalore
Karnataka, 562162 India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr K N Harsha |
Sri Laxmi Hospital |
OPD No 1, Ground Floor, Doddathogur Rd, Electronic City Phase I, Electronic City, Doddathoguru 560100
Bangalore
KARNATAKA |
99009 03344
kolalharsha@yahoo.com |
| Dr Ahish Dakappa |
Vinodha Poly Clinic and diagnostic |
Ground Floor, 65 Meenakshi Building, Hosur Road ,Hebbagodi Bangalore-560100
Bangalore
KARNATAKA |
7795347854
ahishthirthahalli@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| ACE Independent Ethics Committee |
Approved |
| ACE Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R05||Cough. Ayurveda Condition: KASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: HCXK-052501, Reference: NA, Route: Oral, Dosage Form: Asava, Dose: 2.5(ml), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: HCXK-052501 syrup is a non-drowsy formula, with goodness of natural herbal actives along with honey suitable for paediatric age group. | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: HCXK-052501, Reference: NA, Route: Oral, Dosage Form: Asava, Dose: 2.5(ml), Frequency: tds, Bhaishajya Kal: Muhurmuhu, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: HCXK-052501 syrup is a non-drowsy formula, with goodness of natural herbal actives along with honey suitable for paediatric age group. | | 3 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: HCXK-052501, Reference: NA, Route: Oral, Dosage Form: Asava, Dose: 5(ml), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: HCXK-052501 syrup is a non-drowsy formula, with goodness of natural herbal actives along with honey suitable for paediatric age group. |
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Participants who meet all the following criteria will be included in the study:
1.Participants presenting with persistent productive cough due to varied etiology (infective, non-infective, allergic etc.) for less than 3 days duration.
2.Participants presenting with one or more of the following symptoms associated with productive cough: sputum, wheezing, chest congestion, fatigue or awakening from night coughs, shortness of breath, difficulty in talking because of respiratory discomfort.
3.Participants of either gender aged between more than or equal to 2 to less than or equal to 12 years.
4.Participants with mild to moderate cough severity score of 11mm to 70mm on a validated cough visual analogue scale.
5.Participants who agree to refrain from using any other similar medication during the study period (e.g., cough syrups, expectorants, antitussives).
6.Participants who have not participated in any other clinical trial within the past 3 months of screening.
7.Participants/parents who willingly sign informed consent form/oral assent (as applicable) and follow the study procedure as per age group mentioned below:
i.Parents/Guardians/Caregiver related to pediatric participants more than or equal to 2 to less than or equal to 7 years willing to give informed consent for his/her child to participate in the study.
ii.Participants aged more than or equal to 7 to less than or equal to 12 years of age willing to provide oral assent for his/her participation in the study along with parents/guardians/caregiver consent. |
|
| ExclusionCriteria |
| Details |
Participants who meet any one of the following criteria will be excluded from the study:
1.Participants suffering from accompanying illnesses such as bronchiolitis, crepitation in lungs, pneumonia, pleuritis, septic infections, asthma, COPD, fever more than 101 degree F and other chronic respiratory disorders including upper respiratory tract infections with complications.
2. Participants who have received antihistamines, cough suppressants, bronchodilators, mucolytics, expectorants, antibiotics or any other herbal medicines for the control of URTI symptoms 3 days prior to enrollment.
3.Participants who are using nebulizer 1 week prior to enrollment to the study.
4.Participants with known clinically significant cardiovascular, respiratory, cerebrovascular, hepatic, gastrointestinal, autoimmune, endocrinal, congenital or any other systemic disorder that may interfere with the study conduct and outcome in the opinion of the Investigator. (Participants with any chronic medical condition under control to be also excluded).
5.Participants with known history of GI disorders like GERD, Gastritis, abdominal pain, diarrhea, indigestion, or any other discomfort (as assessed by GSRS score more than 2 for any one of the 15 questions to be excluded).
6.Any other conditions (physical, psychological or social) that can interfere with the participants’ compliance to the study in the opinion of the Investigator.
7.A known history or present condition of allergic response to any of the ingredients present in the investigational product.
8.Pre-existing systemic disease necessitating long-term medications.
9.Genetic and endocrinal disorders.
10.Any history of seasonal or perennial allergic rhinitis.
11.Participants/parents whose refused to sign informed consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Efficacy will be assessed by changes in cough severity from baseline to EOS using Cough VAS & Clinical Symptom Evaluation Questionnaire. Determination proportion of participants showing improvement within 3 days & those achieving complete relief. Time to onset of symptomatic relief after the first dose will be recorded. Changes in sputum characteristics from baseline to Day 3 and EOS will be evaluated using Sputum Evaluation Scale. Participant feedback on product experience and effectiveness.
|
Day 1, Day 3 and Day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Safety Endpoints Incidence of AE during the Study period.
|
Day 1, Day 3 and Day 14 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
03/02/2026 |
| Date of Study Completion (India) |
01/04/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
Title: An Open Label, Prospective, Multicentric, Clinical Study to Evaluate the Efficacy and Safety of HCXK-052501 in Pediatric Population with Productive Cough Participants: 50 Duration:14 days (Per participants treatment duration) Product: HCXK-052501 2.5ml for Group 1 and 5ml for Group 2 Visits: Baseline, Day 3 Day 14 Objectives:To evaluate the efficacy and safety of HCXK-052501 in the participants with Productive Cough. Endpoints: Efficacy Endpoints •Reduction in cough severity from baseline to EOS using cough visual analogue scale as evaluated by Investigator. •Percentage of participants showing improvement from cough and related symptoms within 3 days of treatment using cough VAS and clinical symptom evaluation questionnaire as evaluated by Investigator. •Percentage of participants showing complete relief from cough using cough VAS and clinical symptom evaluation questionnaire as evaluated by Investigator. •Reduction in cough related symptoms from baseline to EOS using clinical symptom evaluation questionnaire as evaluated by Investigator. •Time required for onset of action in symptomatic relief from cough symptoms after administration of first dose. •Change in sputum characteristics using sputum evaluation scale from baseline to day 3 and EOS. •Assessment of product experience and effectiveness feedback by participants Safety Endpoints •Incidence of adverse events during the study period. |