| CTRI Number |
CTRI/2025/08/093329 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
19/08/2025 |
| 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
|
Ghanadi Lozenges for Acute Cough relief in Children of 6 to 18 years |
|
Scientific Title of Study
|
Evaluation of the Comparative Efficacy of Ghanadi Lozenges versus Dextromethorphan Lozenges in the management of Vataj Kasa (Acute Cough) in children: A Randomized Controlled Trial |
| 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 NITESH SUBHASH LOKHANDE |
| Designation |
PG SCHOLAR |
| Affiliation |
Mahatma Gandhi Ayurved College, Hospital and Research Centre, Salod(H) Wardha |
| Address |
Room No 41, Department of Kaumarbhritya, Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod(H) Wardha
MAHARASHTRA
442001 India
Wardha
MAHARASHTRA
Wardha
MAHARASHTRA
442001
India |
| Phone |
7506634409 |
| Fax |
|
| Email |
drnitesh99ayucare@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR TRUPTI THAKARE |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi Ayurved College, Hospital and Research Centre, Salod(H) Wardha |
| Address |
Room No 41, Department of Kaumarbhritya, Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod(H) Wardha
MAHARASHTRA
442001 India
Wardha
MAHARASHTRA
Wardha
MAHARASHTRA
442001
India |
| Phone |
7020299894 |
| Fax |
|
| Email |
truptithakre555@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR NITESH SUBHASH LOKHANDE |
| Designation |
PG SCHOLAR |
| Affiliation |
Mahatma Gandhi Ayurved College, Hospital and Research Centre, Salod Hirapur Wardha |
| Address |
Room No 41, Department of Kaumarbhritya, Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod(H) Wardha
MAHARASHTRA
442001 India
Wardha
MAHARASHTRA
Wardha
MAHARASHTRA
442001
India |
| Phone |
7506634409 |
| Fax |
|
| Email |
drnitesh99ayucare@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod Hirapur Wardha Maharashtra India 442001 |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Ayurved College, Hospital and Research Centre |
| Address |
Room No 41, Department of Kaumarbhritya, Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod(H) Wardha.
MAHARASHTRA
442001 India
Wardha
MAHARASHTRA |
| 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 NITESH SUBHASH LOKHANDE |
Mahatma Gandhi Ayurved College, Hospital and Research Centre |
Room No 41, Department of Kaumarbhritya, Mahatma Gandhi Ayurved College, Hospital and Research Centre Salod(H) Wardha.
MAHARASHTRA
442001 India
Wardha
MAHARASHTRA
Wardha
MAHARASHTRA |
7506634409
drnitesh99ayucare@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Ayurved College Hospital and Research Centre Institutional Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R05||Cough. Ayurveda Condition: VATAJAKASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ghanadi Lozenges, Reference: Bhartbhaishya Ratnakar, Part 2 – Kasachikitsaadhikar, 2635, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(NA), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Dextromethorphan Lozenges | A synthetic central NMDA(N-methyl-D-aspartate) receptor antagonist. The d-isomer has antitussive action while the l-isomer is analgesic.
Dextromethorphan does not depress the mucociliary function of the airway mucosa and is practically devoid of constipating action. Though considered nonaddicting, some drug abusers indulge in it.
The Antitussive Action of Dextromethorphan in Cough |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients willing to participate in the study and give written informed assent
2)No previous treatment for the disorder
3)The participants aged 6 to 18, age either gender, with Kasa, who will be recruited from the pediatric institutional OPD
4)Children aged more than 5 years or older with symptoms of Kasa for less than 4 weeks |
|
| ExclusionCriteria |
| Details |
Children with a known case of respiratory problems like: Pneumonia, bronchial asthma, pleurisy, bronchiectasis, tuberculosis, malignancy Subjects with other systemic disorders and metabolic diseases
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Ghanadi lozenges in the management of vataj kasa (acute cough ) based on objective and subjective criteria. |
Treatment daily for 7 days and post-treatment follow-up on the 14th and 60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the efficacy of Dextromethorphan lozenges in the management of vataj kasa (acute cough ) based on objective and subjective criteria.
To assess the reduction in the frequency of cough |
Treatment for 7 Days and post-treatment follow-up on 14th day and 60th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
10/10/2025 |
| 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="2"
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
|
The volunteers will be informed about the study protocol. Willing participants will be randomly
selected as per a computer-generated table. The clinical research format will be prepared
and validated.
Before the study approval is taken from IEC, MGACHRC, Salod (H) Wardha, and CTRI
registration will be done. After selection, each participant will be tested individually and selected
according to the selection criteria. They are divided into two groups. The trial is a Randomized Double blind Equivalence Control Clinical Trial. |