| CTRI Number |
CTRI/2025/09/094479 [Registered on: 09/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy evaluation of Sharbat Toot Siyah (Unani Mulberry Syrup) in Waram-e-Lawzatayn haad (Acute Tonsillitis) in children |
|
Scientific Title of Study
|
Efficacy evaluation of Sharbat Toot Siyah in Waram-e-Lawzatayn haad (Acute Tonsillitis) in children: An open label interventional study |
| 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 Danish |
| Designation |
PG Scholar |
| Affiliation |
State Unani Medical College |
| Address |
Department of Ilmul Atfal, State Unani Medical College and HAHRDM Hospital, Himmatganj
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
9716860786 |
| Fax |
|
| Email |
danishsaifi1155@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 |
| 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 |
| 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 Danish |
| 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 Danish |
State Unani Medical College |
Department of Ilmul Atfal, State Unani Medical College and HAHRDM Hospital, Himmatganj
Allahabad
UTTAR PRADESH |
9716860786
danishsaifi1155@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: J039||Acute tonsillitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Sharbat Toot Siyah |
Sharbat Toot Siyah according to their age twice a day after meal for 14 days
Age group 3 to 6 years given 7 ml twice a day
Age group 7 to 9 years given 10 ml twice a day
Age group 10 to 15 years given 15 ml twice a day |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients of both genders
2 Patients in the age group of 5 and 15 years
3 Clinically diagnosed case waram e lawzatayn haad (acute tonsillitis)
4 Mild and moderate cases of waram e lawzatayn haad (acute tonsillitis) having clinical score less than equal to 8
5 Patients guardian or parents willing to sign the informed consent form and follow the study protocol |
|
| ExclusionCriteria |
| Details |
1 Patients below 5 years of age
2 Patients above 15 years of age
3 Patient with any complication of tonsillitis like peritonsillar abscess, otitis media, sinusitis
4 Tonsillitis associated with any other systemic, or chronic disease like TB, pneumonia, rheumatic fever, meningitis, toxic shock syndrome
5 Use of antibiotics or NSAIDs or Analgesics or Antipyretics or Antihistamine in the previous one week
6 Patient is unsure about attending schedule regularly |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in clinical score and PGA |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in acute tonsillitis symptoms: enlarged tonsils, dysphagia, odynophagia, sore throat, fever, tender cervical lymph nodes. |
14 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/09/2025 |
| Date of Study Completion (India) |
08/05/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 is being conducted to evaluate the effectiveness and safety of Sharbat Toot Siyah, a traditional herbal syrup made from black mulberries, in the treatment of acute tonsillitis in children. Forty patients between 5 and 15 years of age with mild to moderate tonsillitis will be enrolled in an open label interventional study. The intervention will be given for 14 days and patients will be assessed at baseline, day 7 and day 14. The main outcomes are change in clinical score and patient global assessment. Secondary outcomes include improvement in throat pain, fever, difficulty in swallowing, tonsil swelling, and lymph node tenderness. Safety will be assessed by routine laboratory investigations. The study hypothesis is that Sharbat Toot Siyah is effective in reducing the symptoms of acute tonsillitis in children. |