| CTRI Number |
CTRI/2026/01/101884 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| 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
|
Effect of Aurosickle Tablet versus Standard Treatment on Quality of Life in School Going Children with Sickle Cell Disease |
|
Scientific Title of Study
|
An Open Label Controlled Clinical Trial For Comparative Analysis Of The Effect Of Standard Drug With Tablet Aurosickle In The Management Of Sickle Cell Disease In School Going 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 Toshi Patidar |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute Of Ayurveda Vadodara Gujarat |
| Address |
room no -204 Department Of Kaumarbhritya Parul Institute Of Ayurveda Vadodara Gujarat
room no -204 Department Of Kaumarbhritya Parul Institute Of Ayurveda Vadodara Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9575161813 |
| Fax |
|
| Email |
toshipatidar123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swapnil Raskar |
| Designation |
Professor |
| Affiliation |
Parul Institute Of Ayurveda Vadodara Gujarat |
| Address |
room no - 204 Department Of Kaumarbhritya Parul Institute Of Ayurveda Vadodara Gujarat
room no - 204 Department Of Kaumarbhritya Parul Institute Of Ayurveda Vadodara Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9726587013 |
| Fax |
|
| Email |
swapnil.raskar@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swapnil Raskar |
| Designation |
Professor |
| Affiliation |
Parul Institute Of Ayurveda Vadodara Gujarat |
| Address |
room no - 204 Department Of Kaumarbhritya Parul Institute Of Ayurveda Vadodara Gujarat
room no - 204 Department Of Kaumarbhritya Parul Institute Of Ayurveda Vadodara Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9726587013 |
| Fax |
|
| Email |
swapnil.raskar@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Parul Institute Of Ayurveda Vadodara Gujarat Pin Code 391760 |
|
|
Primary Sponsor
|
| Name |
Parul Institute Of Ayurveda Vadodara Gujarat |
| Address |
Department of Kaumarbhritya Parul Institute Of Ayurveda Vadodara Gujarat Pin Code 391760 |
| 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 Toshi Patidar |
Room no 204 Department of kaumarbhritya Parul University Vadodara |
Parul Institute Of Ayurveda Vadodara Gujarat Pin Code 391760
Vadodara
GUJARAT |
9575161813
toshipatidar123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Parul Institute Of Ayurved Parul University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D570||Hb-SS disease with crisis. Ayurveda Condition: PANDU, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Aurosickle, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 6 Weeks, anupAna/sahapAna: Yes(details: water), Additional Information: Dose - 3 to 5 year - Half tablet QID after food
6-9years - one tablet TDS after food
10-13years - one tablet QID after food
14-16years - two tablet TDS after food | | 2 | Comparator Arm (Non Ayurveda) | Drug | Classical | | (1) Medicine Name: Ibuprofen , Reference: Nelson Textbook Of Pediatrics , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 15(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 6 Weeks, anupAna/sahapAna: Yes(details: -water), Additional Information: - | | 3 | Comparator Arm (Non Ayurveda) | Drug | - | | |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Confirmed diagnosis of SCD
Recent history of pain crisis often defined as more 2-3 episodes in the past year
Current vaso-occlusive pain requiring hospitalisation or outpatient management
|
|
| ExclusionCriteria |
| Details |
Age less than 3 years and greater than 16 years
Pain associated with acute chest syndrome respiratory distress deep vein thrombosis pulmonary embolism gall bladder disease neuropathic pain etc
Infections such as osteomyelitis septic arthritis pneumonia or other infections |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce pain crisis in sickle cell disease. |
day 7 day 14 day 21 day 28 day 35 day 42 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To improve quality of life of sickle cell patients. |
day 7 day 14 day 21 day 28 day 35 day 42 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
05/02/2026 |
| 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 - NO
|
|
Brief Summary
|
The volunteers will be informed about the study protocol Willing participants will be selected The clinical research format will be prepared and validated Prior to the study approval will be
taken from IEC PIA Parul university vadodara and CTRI registration will be done After selection each participant will be tested individually and selected according to selection criteria Participant will be divided in two groups one group will receive Aurosickle tablet and another group will receive Ibuprofen tablet it will
include 6 week treatment and follow up |