| CTRI Number |
CTRI/2025/07/091233 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
05/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to Compare the Effects of Tekrajras Syrup and Levosalbutamol Syrup in Treating Cough Caused by Kapha in Children
|
|
Scientific Title of Study
|
Randomized controlled clinical trial to compare the efficacy of oral administration of tekrajras syrup with levosalbutamol syrup in kaphaj kasa 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 Shivaji Sarjerao Ghongade |
| Designation |
PG Scholar |
| Affiliation |
Tilak Ayurved Mahavidyalaya,Pune |
| Address |
Tilak ayurved mahavidyalaya,1st floor,Department of Kaumarbhritya,rasta peth,pune
Pune
MAHARASHTRA
401107
India |
| Phone |
8108605474 |
| Fax |
|
| Email |
ghongadeshivaji@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VIKAS BHARAT JAYBHAY |
| Designation |
HEAD OF DEPARTMENT AND ASSI. PROF |
| Affiliation |
TILAK AYURVEDIC MAHAVIDYALAYA PUNE |
| Address |
Tilak ayurved mahavidyalaya,1st floor,Department of Kaumarbhritya,rasta peth,pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9422377863 |
| Fax |
|
| Email |
vikasjaybhay110@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR VIKAS BHARAT JAYBHAY |
| Designation |
HEAD OF DEPARTMENT AND ASSI. PROF |
| Affiliation |
TILAK AYURVEDIC MAHAVIDYALAYA PUNE |
| Address |
tilak ayurved mahavidyalaya,1st floor,Department of Kaumarbhritya,rasta peth,pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9422377863 |
| Fax |
|
| Email |
vikasjaybhay110@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tilak ayurved mahavidyalaya,1st floor,Department of Kaumarbhritya,583/2,rasta peth,pune,411011,mahaashtra,india |
|
|
Primary Sponsor
|
| Name |
TILAK AYURVED MAHAVIDYALAYA |
| Address |
Tilak ayurved mahavidyalaya,1st floor,Department of Kaumarbhritya,rasta peth,pune,maharashtra,411011 |
| Type of Sponsor |
Private medical college |
|
|
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 Shivaji Ghongade |
Seth Tarachand Ramnath Ayurvedic Hospital Pune |
Seth Tarachand Ramanath Dharmarth Ayurved Hospital,Rasta Peth,Pune,maharashtra,411011
Pune
MAHARASHTRA |
8108605474
ghongadeshivaji@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional ethical committe, TAMV pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J398||Other specified diseases of upperrespiratory tract. Ayurveda Condition: KASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: TEKRAJRAS SYRUP, Reference: Panditrao DB. Sahastrayoga,churn prakaran,page no 184, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 6.5(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: lukewarm water), Additional Information: dose:0.66ml/kg/day 8 hrly | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: LEVOSALBUTAMOL SYRUP, Reference: Tripathi KD. Essentials of Medical Pharmacology. 7th Ed, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 7.5(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: dose:0.05-0.2mg/kg/day 8 hrly |
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. Participant having classical signs and symptoms like Aruchi, Shirshula, Pinasa, kaphaj kasa etc.
2. Age group 4 to 10 years
3. Both male and female children will be included
4. Participant suffering from kaphaj kasa less than 7 days |
|
| ExclusionCriteria |
| Details |
1. Kasa Other Than Kaphaj Kasa
2. Participant Having Respiratory Distress Syndrome Like Tachypnea,Nasal Flaring,Retraction Etc
3. Kasa More Than 7 Days And Other Disease Of Respiratoey Tract Like Lrti,Copd,Asthma,Emphysema And Febrile Condition Etc
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease In Kasa |
3 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease In Kasa And Kapha Production,Aruchi,Shirshula,Pratishyaya |
7 Days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
31/07/2025 |
| 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="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
|
The study will be intervened by the treatment of Tekrajras syrup and Levosalbutamol syrup to group A and group B respectively. The efficacy of the
therapy will be assessed on the basis of subjective and objective criteria for statistical
analysis. Scoring will be designed according to the severity of symptoms. The
subjective and objective gradation of symptoms will be done as follows and the
intensity of each symptom will be calculated before treatment, after treatment and
after follow up. The effect of treatment result will be assessed in regards to clinical
signs and symptoms on the basis of grading and scoring system. The signs and
symptoms will be assessed by adopting the suitable scoring method. |