| CTRI Number |
CTRI/2025/12/099551 [Registered on: 19/12/2025] Trial Registered Prospectively |
| Last Modified On: |
18/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Throat Irritation with Unani Medicine Qurse-Tabasheer Mulaiyin. |
|
Scientific Title of Study
|
A single-arm, multicentre, clinical validation study to Evaluate the Safety and Efficacy of a Unani Pharmacopoeial formulation, Qurs-e-Tabasheer Mulaiyin in Khushanat-i-Halq (Irritation of Throat) |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| KH/IT/QTM/CLNVAL/CCRUM/23-24, Version No-02, 13.06.2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr N Zaheer Ahmed |
| Designation |
Director General |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 502, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri South West
South West
DELHI
110058
India |
| Phone |
01128525715 |
| Fax |
|
| Email |
drnzaheer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Younis I Munshi |
| Designation |
Deputy Director General |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 507, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri South West India
South West
DELHI
110058
India |
| Phone |
09419086700 |
| Fax |
|
| Email |
younismunshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Kumar |
| Designation |
Research Officer (Pathology) S-IV |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 516, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri South West DELHI India
South West
DELHI
110058
India |
| Phone |
08800263300 |
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support:
1. National Research Institute of Unani Medicine for Skin Disorders, Opp. E.S.I., Hospital, A.G. Colony Road, Erragadda, Hyderabad–500838
2. Regional Research Institute of Unani Medicine, Chandbali Bypass Road, Near Rural Police Station, Bhadrak–756100 |
| Monetary Support : Central Council for Research in Unani Medicine (CCRUM),Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058
|
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohd Azam |
National Research Institute of Unani Medicine for Skin Disorders |
Research OPD Room Khushunat-e-Halaq (Irritation of Throat), Opp. E.S.I., Hospital, A.G. Colony Road, Erragadda, Hyderabad – 500838
Hyderabad
TELANGANA |
8707639181
mohdazam.ccrum@ccrum.res.in |
| Dr M A waheed |
Regional Research Institute of Unani Medicine |
Research OPD Room Khushunat-e-Halaq (Irritation of Throat), Chandbali Bypass Road, Near Rural Police Station, Bhadrak–756100
Bhadrak
ORISSA |
9347351749
mawaheed313@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| National Research Institute of Unani Medicine for Skin Disorders, Hyderabad |
Approved |
| Regional Research Institute of Unani Medicine, Bhadrak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J02||Acute pharyngitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Qurs-e-Tabasheer Mulaiyin |
2 Tab Twice daily taken orally with lukewarm water for 14 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients having Throat irritation with or without any of the following symptoms:
1. Hoarseness of voice
2. Dysphagia
3. Cough
4. Pharyngeal erythema
5. Pain in throat
6. Post nasal drip
|
|
| ExclusionCriteria |
| Details |
1. Known cases of fungal and bacterial pharyngitis.
2. Patients with all classic symptoms of Group A Streptococcal Pharyngitis:
i. Red and swollen tonsils
ii. Tonsillar exudates (white patches /streaks of pus)
iii. Swollen, tender anterior cervical lymph nodes
iv. Absence of cough
3. High grade fever
4.Known cases of Epiglottises.
5. Known cases of Oral candidiasis.
6. Known cases of Herpes simplex.
7.Known cases of Renal or Hepatic or Cardiac ailments.
8.Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in the signs and symptoms of Khushunat-e-Halaq (Irritation of Throat). Which will be assessed on the basis of the VAS score. |
At baseline, first follow up and at the end of treatment. (i.e., 0, 7th and 14th day) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical investigations for safety assessment i.e.,Haemogram, AEC, LFT, KFT, CRP and Urine R/M. |
At baseline, first follow up and at the end of treatment. i.e., 0, 7th and 14th day
|
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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 |
|
Date of First Enrollment (India)
|
30/12/2025 |
| 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="2"
Months="0"
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 study is designed as a multi centric open trial in patients with Khushunat-e-Halaq (Irritation of Throat) . After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at baseline, first follow up and at the end of treatment. (i.e., 0, 7th and 14th day) . This includes subjective assessment of general well being and physical examination. The total duration of treatment will be 14 Days. Laboratory parameters for safety assessment will be conducted at baseline, first follow up and on completion of the protocol therapy (i.e., 0, 7th and 14th day).
Composition of Study drug: Qurs-e-Tabasheer Mulaiyin | S. No. | Ingredients | Scientific/Botanical name | Quantity | | 1. | Tabasheer | Bambusa arundinaceae (Retz.) Roxb. | 4 parts | | 2. | Turanjabeen | Alhagi pseudalhagi (Bieb.) Desv | 3 parts | | 3. | Maghz-e-Tukhm-e-Khiyarain | Cucumis sativa seed | 1 part | | 4. | Maghz-e-Tukhm-e-Kaddu | Laginaria siceraria seed | 1 part | | 5. | Nishasta-e-Gandum | Triticum sativum | 1 part | | 6. | Samgh-e-Arabi | Acacia arabica | 1 part | | 7. | Kateera | Tragacanth gum | 1 part | | 8. | Khashkhaash Safaid | Papaver somniferum seed | 1 part | | 9. | Loab-e-Aspaghol | Plantago ovata Forsk | Q.S. |
|