| CTRI Number |
CTRI/2025/07/090826 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Thippili Rasayanam for Childhood Asthma: A Safety and Efficacy Study |
|
Scientific Title of Study
|
Preclinical and Clinical evaluation of the Safety and efficacy of Thippili Rasayanam in the treatment of Iraippu Noi (Childhood Asthma) in children. |
| Trial Acronym |
TPRFCA-Thippili Rasayanams for Childhood Asthma |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIS/25/IEC/2023/Ph.D./31 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHALINI B |
| Designation |
Full time Ph.D scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Dept. of Kuzhandhai Maruthuvam, National Institute of Siddha,Chennai,India.
Ramachandra nagar 3rd street,Amutha flats 1st floor,Iyyappanthangal,Chennai-600056.
Chennai
TAMIL NADU
600047
India |
| Phone |
09962700199 |
| Fax |
|
| Email |
drshalini.mdsiddha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
KSuresh |
| Designation |
Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Dept. of Kuzhandhai Maruthuvam, National Institute of Siddha,Chennai,India.
Dept. of Kuzhandhai Maruthuvam, National Institute of Siddha,Chennai,India.
Chennai
TAMIL NADU
600047
India |
| Phone |
9962571137 |
| Fax |
|
| Email |
drsureshherbal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KSuresh |
| Designation |
Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Dept. of Kuzhandhai Maruthuvam, National Institute of Siddha,Chennai,India.
Dept. of Kuzhandhai Maruthuvam, National Institute of Siddha,Chennai,India.
Chennai
TAMIL NADU
600047
India |
| Phone |
9962571137 |
| Fax |
|
| Email |
drsureshherbal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Thippili Rasayanam (herbal formulation) and standard Childhood asthma care evaluating by Spirometry test
|
|
|
Primary Sponsor
|
| Name |
National institute of Siddha |
| Address |
GST Road,Tambaram sanatorium,
Chennai-47 |
| 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 |
| Shalini B |
National Institute of Siddha |
Dept. of Kuzhandhai Maruthuvam, National Institute of Siddha,Chennai,India.
Chennai
TAMIL NADU |
09962700199
drshalini.mdsiddha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J454||Moderate persistent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Thippili Rasayanam |
Thippili Rasayanam administered orally for 40 days access the pre and post treatment, |
| Intervention |
Thippili Rasayanam |
Thippili Rasayanam formulation (herbal medicine) for Childhood asthma administered orally for 40 days |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Children aged 6 years and 12 years old at time of giving consent
2. Children with symptoms of Wheezing, Cough, difficulty in breathing, Tightness of Chest as per IAP 2022 Asthma guidelines
3. History of wheezing more than three episodes in a year.
4. Patients having Spirometry values within ranges [FEV1]
5. Willing to sign consent and assent forms.
6. Patient willing to attend the OPD once in 7 days for 40 days.
|
|
| ExclusionCriteria |
| Details |
1. Any other lung disease other than Asthma.
2. Patients unable to perform Spirometry test.
3. Patients who are in the process of another clinical research.
4. Children with any other active systemic illnesses
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Efficacy of the trial drug is measured by Spirometry test (FEV1) on 0th,22th and 40th day treatment and improvement in the clinical condition will be determined through in this data.
• Changes in the clinical symptoms will be recorded by Asthma control Questionnaire at each visit (Once in 7 days) for 40 days.
|
Pre-treatment, post-treatment (40 days), and follow-up (3 months)".
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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 3 |
|
Date of First Enrollment (India)
|
03/11/2025 |
| 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="0"
Months="6"
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
|
This study aims to evaluate the safety and efficacy of Thippili Rasayanam in children with asthma.Patients are enrolled in this study based on the inclusion and exclusion criteria. A diagnosis of Childhood Asthma will be provisionally diagnosed in patients with recurrent cough, wheeze, tightness of chest, difficulty in breathing, and will be confirmed using objective measures of Spirometry test. The trail drug Thippili Rasayanam as internal medicine will be given for 40 days and the patient will be requested to attend the OPD once in 7 days for 40 days. Changes in the clinical symptoms will be recorded by Asthma control Questionnaire at each visit. This study will be evaluated by using Spirometry test for Iraippu noi (Childhood Asthuma) on pre and post treatment. After the completion of the treatment, the patient is advised to visit our OPD for follow up for three months. |