| CTRI Number |
CTRI/2025/08/093767 [Registered on: 27/08/2025] Trial Registered Prospectively |
| Last Modified On: |
26/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Unani Polyherbal Approach for Chronic Tonsillitis. |
|
Scientific Title of Study
|
To Evaluate The Clinical Efficacy Of Polyherbal Unani Formulation in The Management of Waram Al Lawzatayn Muzmin(Chronic Tonsillitis). |
| Trial Acronym |
CT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KM Nasreen |
| Designation |
PG Scholar |
| Affiliation |
State Unani Medical College Himmatganj Prayagraj Uttar Pradesh Pin Code 211016 |
| Address |
Departmant of Amraz-e-Ain Uzn Anf Halaq Wa Asnan,State Unani Medical College and HAHRDM Hospital Himmatganj, Prayagraj
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
7071070908 |
| Fax |
|
| Email |
nasreenkhan7052@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Usamah Ahmad |
| Designation |
Reader |
| Affiliation |
State Unani Medical College Himmatganj Prayagraj Uttar Pradesh Pin Code 211016 |
| Address |
Departmant of Amraz-e-Ain Uzn Anf Halaq Wa Asnan,State Unani Medical College and HAHRDM Hospital Himmatganj, Prayagraj
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
9415639877 |
| Fax |
|
| Email |
arogyaherbal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KM Nasreen |
| Designation |
PG Scholar |
| Affiliation |
State Unani Medical College Himmatganj Prayagraj Uttar Pradesh Pin Code 211016 |
| Address |
Departmant of Amraz-e-Ain Uzn Anf Halaq Wa Asnan,State Unani Medical College and HAHRDM Hospital Himmatganj, Prayagraj
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
7071070908 |
| Fax |
|
| Email |
nasreenkhan7052@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Unani Medical College Himmatganj Prayagraj Uttar Pradesh Pin Code 211016 |
|
|
Primary Sponsor
|
| Name |
State Unani Medical College and HAHRDM Hospital Himmatganj Prayagraj |
| Address |
State Unani Medical College and HAHRDM Hospital Himmatganj Prayagraj Uttar Pradesh Pin code 211016 |
| 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 |
| KM Nasreen |
State Unani Medical College and HAHRDM hospital |
OPD no.6,Departmant of Amraz-e-Ain Uzn Anf Halaq Wa Asnan,Ground Floor,State Unani Medical College and HAHRDM Hospital Himmatganj, Prayagraj Pin Code 211016
Allahabad
UTTAR PRADESH |
07071070908
nasreenkhan7052@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committtee(IEC) for Biomedical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J359||Chronic disease of tonsils and adenoids, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Polyherbal Unani Formulation(Decoction) |
Patient will be given decoction(Joshanda) twice a day for 42 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of either gender in the age group of 18-50 years.
2.Clinically diagnosed cases of Waram-e-Lawzatayn Muzmin (chronic tonsillitis)
3. Clinical Scoring System
Severe- 9 or greater than 9.
Moderate- 4-8
Mild- 3 or less than 3.
|
|
| ExclusionCriteria |
| Details |
1.Patients aged below 18 years and more than 50 years
2.Pregnant and lactating women
3.Patient with any complication of tonsillitis
4.Tonsillitis associated with any other systemic, metabolic, or chronic disease
5.Patient ’s unsure about attending schedule regularly. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in clinical scoring system |
7,14,21,28,35,and 42 days from baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in patient global assessment on Visual Analog Scale (VAS) |
7,14,21,28,35 and 42 Days from baseline |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
12/09/2025 |
| 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
|
The proposed clinical study aims to evaluate the
effectiveness of a polyherbal Unani formulation in managing Waram
al-Lawzatayn Muzmin (Chronic Tonsillitis), a common ENT condition marked by
recurrent throat infections, especially among children and young adults. Modern
treatments like antibiotics offer temporary relief and come with side effects,
often leading to surgical intervention such as tonsillectomy. In contrast,
Unani medicine offers natural, safer alternatives with minimal adverse effects.
Drawing from classical Unani texts and modern clinical observations, this study
involves a 6-week, open-label, pre-post interventional trial with 50 patients
aged 18–50 years. Participants will receive a herbal decoction comprising
ingredients like Anjeer, Marzanjosh, Qust, Tulsi, and others. The study will
assess efficacy based on clinical symptoms and laboratory parameters, aiming to
explore a holistic, effective, and safer long-term approach to treating chronic
tonsillitis through Unani medicine. |