| CTRI Number |
CTRI/2026/04/108142 [Registered on: 10/04/2026] Trial Registered Prospectively |
| Last Modified On: |
06/04/2026 |
| 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 EFFECT OF BHARANGYADI AVALEHA AND KARPURADI AVALEHA IN TREATING DRY COUGH IN CHILDREN OF AGE 5 TO 12 YEARS. |
|
Scientific Title of Study
|
A RANDOMISED CONTROLLED CLINICAL TRIAL TO COMPARE THE EFFICACY OF ORAL ADMINISTRATION OF BHARANGYADI AVLEHA WITH KARPURADI AVLEHA IN VATAJ KASA IN CHILDREN WITH AGE GROUP 5 TO 12 YEARS. |
| 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 Shubhangi Rajesh Nalawade |
| Designation |
Pg Scholar |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
583/2,Tilak Ayurved Mahavidyalaya, 1st Floor, Department of Kaumarbhritya , Jagtap Rd, Rasta Peth,Pune, Maharashtra 411002
Pune
MAHARASHTRA
411002
India |
| Phone |
9921441166 |
| Fax |
|
| Email |
nalawade931@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikas B Jaybhay |
| Designation |
HOD, Department of Kaumarbhritya |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
583/2Tilak Ayurved Mahavidyalaya, 1st Floor, Department of Kaumarbhritya Jagtap Rd, Rasta Peth,Pune, Maharashtra 411002
Pune
MAHARASHTRA
411002
India |
| Phone |
9422377863 |
| Fax |
|
| Email |
vikasjaybhay110@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikas B Jaybhay |
| Designation |
HOD, Department of Kaumarbhritya |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
583/2Tilak Ayurved Mahavidyalaya, 1st Floor, Department of Kaumarbhritya Jagtap Rd, Rasta Peth,Pune, Maharashtra 411002
Pune
MAHARASHTRA
411002
India |
| Phone |
9422377863 |
| Fax |
|
| Email |
vikasjaybhay110@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth Tarachand Ramnath Charitable Ayurvedic Hospital, 580/2 Rasta Peth, Pune, 411011 |
|
|
Primary Sponsor
|
| Name |
TILAK AYURVED MAHAVIDYALAYA |
| Address |
Tilak Ayurved Mahavidyalaya , 1st Floor, Department of Kaumarbhritya ,583/2, Jagtap Rd, Rasta Peth, Pune, Maharashtra 411002 |
| 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 Shubhangi Rajesh Nalawade |
Seth Tarachand Ramnath Charitable Ayurvedic Hospital. |
Tilak Ayurved Mahavidyalaya, 1st floor, Kaumarbhritya department, Rastapeth, 583/2, Pune 411011.
Pune
MAHARASHTRA |
09921441166
nalawade931@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tilak Ayurved Mahavidyalaya,Pune. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J988||Other specified respiratory disorders. Ayurveda Condition: KASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bharangyadi Avaleha, Reference: Chakradatta Kasa Chikitsa Prakaran, 11/7 , Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -Dose: 5 to 10 years - 3 to 6 gms twice a day ; 11 to 12 years - 6 to 8 gms , twice a day | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Karpuradi Avaleha , Reference: Arogya Raksha Kalpadrum, Panchamoadhaya, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -Dose: 5 to 10 years - 3 to 6 gms twice a day ; 11 to 12 years - 6 to 8 gms , twice a day |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1)Children having symptoms of Vataj kasa.
2)Children of age group 5 year to 12 years.
3)Acute cough of maximum duration upto 7 days. |
|
| ExclusionCriteria |
| Details |
1)Chronic dry cough, productive cough, any other disease of respiratory tract like LRTI, COPD, Asthama, Emphysema and febrile conditions, etc.
2)Age less than 5 year and greater than 12 years.
3)Children having respiratory distress |
|
|
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 symptoms of kasa |
Decrease in symptoms of kasa in 5 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in symptoms of shushka- kasa,hrithparswashool,swarabheda |
7 days |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
22/04/2026 |
| 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="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 - YES
- What data in particular will be shared?
Response (Others) -
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identiļ¬ed for this purpose.
- For what types of analyses will this data be available?
Response (Others) -
- By what mechanism will data be made available?
Response - Proposals should be directed to [nalawade931@gmail.com].
- For how long will this data be available start date provided 02-03-2026 and end date provided 02-11-2027?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
The study will be intervened by the treatment of Bharangyadi avaleha and Karpuradi avaleha 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. |