| CTRI Number |
CTRI/2025/01/079173 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
20/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The study between Trikatu choorna and Nidhigdhikadi choorna in common cold. |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF TRIKATU CHOORNA IN KAPHAJA PRATISHYAYA IN CHILDREN |
| 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 Mamata Mallayya Hiremath |
| Designation |
PG scholar |
| Affiliation |
Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodubidire, Dakshina Kannada |
| Address |
Department of Kaumarbhritya opd balaroga room no:2
Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodubidire,Dakshina Kannada
Karnataka
574227
Department of Kaumarbhritya opd balaroga room no:2
Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodubidire,Dakshina Kannada
Karnataka
574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
7624992700 |
| Fax |
|
| Email |
momgmh1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Narayan Pai B |
| Designation |
Professor |
| Affiliation |
Alvas Ayurveda Medical College and Hospital, Vidyagiri , moodubidire , Dakshina Kannada |
| Address |
Department of Kaumarbhritya opd balaroga room no:2
Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodubidire,Dakshina Kannada
Karnataka
574227
Department of Kaumarbhritya opd balaroga room no:2
Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodubidire,Dakshina Kannada
Karnataka
574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9902329719 |
| Fax |
|
| Email |
drnarayanpai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Narayan Pai B |
| Designation |
Professor |
| Affiliation |
Alvas Ayurveda Medical College and Hospital, Vidyagiri , moodubidire , Dakshina Kannada |
| Address |
Department of Kaumarbhritya opd balaroga room no:2
Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodubidire,Dakshina Kannada
Karnataka
574227
Department of Kaumarbhritya opd balaroga room no:2
Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodubidire,Dakshina Kannada
Karnataka
574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9902329719 |
| Fax |
|
| Email |
drnarayanpai@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas Ayurveda Medical College and Hospital, Moodubidire , Dakshina Kannada , 574227 .
Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Dr Mamata Mallayya Hiremath |
| Address |
Alvas Ayurveda Medical College and Hospital, Moodubidire, Dakshina Kannada, Karnataka
574227 |
| Type of Sponsor |
Other [Self ] |
|
|
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 Mamata Mallayya Hiremath |
Alvas Ayurveda Medical College and Hospital, Moodubidire , Dakshina Kannada, Karnataka |
Department of Kaumarbhritya opd balaroga room no:2
Alvas Ayurveda Medical College and Hospital Moodubidire, Dakshina Kannada,Karnataka
574227
Dakshina Kannada
KARNATAKA |
7624992700
momgmh1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Alvas Ayurveda Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J00||Acute nasopharyngitis [common cold]. Ayurveda Condition: PRATISYAYAH/PINASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Trikatu choorna, Reference: Vangasena samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5.5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Dosage-
6-8years =3.5grams &
9-12 years =5.5grams
|
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of either gender between the age group of 6-12 years.
2. Patients who are fulfilling the diagnostic criteria, will be selected |
|
| ExclusionCriteria |
| Details |
1.Cases which require surgical interventions like nasal polyps, etc.
2. Patients having any other systematic illness will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To check and assess the following parameters
sneezing
number of sneezing in a day
redness of eyes
nasal discharge
headache
|
14days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to reduced the occurrence of
sneezing
nasal discharge
redness of eyes
headache |
14days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
04/02/2025 |
| 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="6"
Days="15" |
|
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 study is randomized, parallel group, actively controlled comparative clinical study with Nidigdhikadi choorna as standard drug and Trikatu choorna as interventional drug with the dosage of 3.5gms for 6 to 8 years and 5.5gms for 9 to 12 years to be given twice a day before food with madhu as anupana, The study will be conducted on subjects having Kaphaja Pratishyaya belonging to age group of 6 to 12 years who has given written and verbal consent by parents for undergoing clinical study. The study will be conducted in Alvas Ayurveda Medical College and Hospital, Moodubidire. Interventional period of the study is 14days and assessment will be done before treatment, 3rd day, 7th day and 14th day, |