| CTRI Number |
CTRI/2025/10/096099 [Registered on: 15/10/2025] Trial Registered Prospectively |
| Last Modified On: |
15/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the Effects of Sharbat Khaksi versus Paracetamol in Children with Typhoid Fever Who Are Also Receiving Antibiotic Treatment. |
|
Scientific Title of Study
|
Therapeutic Evaluation of Sharbat Khaksi and Cefixime vs Paracetamol and Cefixime in Pediatric Typhoid Fever: A Randomized Parallel Arm Open Label Interventional Clinical Trial |
| 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 Sudhanshu |
| Designation |
PG Scholar |
| Affiliation |
State Unani Medical College and Hospital Himmatganj Prayagraj |
| Address |
Department of Ilmul Atfal, State Unani Medical College and HAHRDM Hospital, Himmatganj
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
8318869581 |
| Fax |
|
| Email |
sudhanshukartik999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Md Sohail |
| Designation |
Assistant Professor and Head of Department In-Charge |
| Affiliation |
State Unani Medical College and Hospital Himmatganj Prayagraj |
| Address |
Department of Ilmul Atfal, State Unani Medical College and HAHRDM Hospital, Himmatganj
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
8279944096 |
| Fax |
|
| Email |
shlt869@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Md Sohail |
| Designation |
Assistant Professor and Head of Department In-Charge |
| Affiliation |
State Unani Medical College and Hospital Himmatganj Prayagraj |
| Address |
Department of Ilmul Atfal, State Unani Medical College and HAHRDM Hospital, Himmatganj
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
8279944096 |
| Fax |
|
| Email |
shlt869@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Unani Medical College and Hospital, Himmatganj, Prayagraj, UP, India 211016 |
|
|
Primary Sponsor
|
| Name |
Dr Sudhanshu |
| Address |
Department of Ilmul Atfal, State Unani Medical College and HAHRDM Hospital, Himmatganj, Prayagraj, UP, India 211016 |
| 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 Sudhanshu |
State Unani Medical College |
Department of Ilmul Atfal, State Unani Medical College and HAHRDM Hospital, Himmatganj
Allahabad
UTTAR PRADESH
Allahabad
UTTAR PRADESH |
8318869581
sudhanshukartik999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Biomedical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A010||Typhoid fever, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Paracetamol and Cefixime |
The patient will be given Paracetamol (PCM 250/5ml oral suspension) 15mg/kg/dose orally thrice a day after meal and Cefixime (Zifi 100mg/5ml) 20mg/kg/day in two divided dose orally after meal for 7 days. |
| Intervention |
Sharbat Khaksi and Cefixime |
The patients will be given Sharbat Khaksi (as per body weight which is less than or equall to 15 kg is 5ml, more than 15 kg to less than or equall to 23 kg is 8.5ml, more than 23 kg to less than or equall to 40 kg is 12ml and more than 40 kg is 15ml) thrice a day orally after meal and Cefixime (Zifi 100mg/5ml) 20mg/kg/day in two divided dose orally after meal for 7 days. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
A history of fever and presentation for more than or equals to 72 hours and a documented fever [99.5 degree fahrenheit to 102 degree fahrenheit (axillary)].
Cases of positive Blood culture of S typhi
Patients whose parents or guardian or LAR will give consent and able to do follow-up.
|
|
| ExclusionCriteria |
| Details |
Patients who had received intravenous or oral antibiotics before getting Blood culture of S typhi.
Clinically diagnosed cases of malaria and dengue.
Patients with known other systemic disease.
Previous history of hypersensitivity to any of the trial drugs.
Complicated typhoid fever cases suffers from melena, severe abdominal discomfort, hepatic encephalopathy.
Any concomitant treatment like anti-depressants or anticonvulsants
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fever clearance time (FCT) |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in other Subjective parameters |
14 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
|
N/A |
|
Date of First Enrollment (India)
|
14/11/2025 |
| 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="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
|
This is a randomized, open-label, parallel-arm clinical trial to compare the efficacy of a Unani formulation, Sharbat Khaksi, against Paracetamol in managing fever for pediatric typhoid. The study will enroll 70 children aged 5-12 years with blood culture-confirmed uncomplicated typhoid fever. Participants will be randomly assigned to either the trial group, receiving Sharbat Khaksi and Cefixime, or the control group, receiving Paracetamol and Cefixime, for a duration of 14 days. The primary objective is to evaluate the difference in Fever Clearance Time (FCT) between the two groups. Secondary outcomes will include the assessment of improvement in subjective symptoms like weakness, fatigue, headache, and abdominal pain, with follow-ups on days 3, 6, 8, and 14. |