| CTRI Number |
CTRI/2025/08/092663 [Registered on: 08/08/2025] Trial Registered Prospectively |
| Last Modified On: |
26/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Common Cold (Nazla) with Unani Medicine Lauq-e-Nazli |
|
Scientific Title of Study
|
Clinical Validation of Unani Pharmacopoeial Formulation Lauq-e-Nazli in Nazla(Common Cold) |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| N/CC/LN/CLN/VLDN/2023-24, Version No-01, 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
West
DELHI
110058
India |
| Phone |
01128525715 |
| Fax |
|
| Email |
drnzaheer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ghazala Javed |
| Designation |
Assistant Director (Unani) |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 506,
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
West
DELHI
110058
India |
| Phone |
9811810454 |
| Fax |
|
| Email |
javed.ghazal@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
West
DELHI
110058
India |
| Phone |
8800263300 |
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support :1 Regional Research Institute of Unani Medicine, D-11/1, AbulFazal Enclave, Jamia Nagar, Okhla, New Delhi – 110025. 2. Regional Research Institute of Unani Medicine, Chandbali Bypass Road, Bhadrak –756100 (Orissa) 3. Clinical Research Unit, Kurupatil Nina Memorial, Near Panchayat Office,Kerala- 683564 4.Clinical Research Unit, Burhanpur –450331 |
| 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 CCRUM New Delhi |
| 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 = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Yasmin Fatima |
Clinical Research Unit, Burhanpur |
Research OPD Room Nazla(Common Cold),S. H. Unani Tibbiya College, Ganpati Naka, Burhanpur – 450331 (M.P.)
East Nimar
MADHYA PRADESH |
8827166845
yas.fatima2014@gmail.com |
| DR A Farhath Fathima |
Clinical Research Unit, kerala |
Research OPD Room Nazla(Common Cold),Kurupatil Nina Memorial, Near Panchayat Office, P. O. Edathala (N) – 683564 Alweye, Kerala
Ernakulam
KERALA |
9941767447
f.fathima@ccrum.res.in |
| Dr Mohammed Wasim Ahmed |
Regional Research Institute of Unani Medicine |
Research OPD Room Nazla(Common Cold),D-11/1, AbulFazal Enclave,
Jamia Nagar, Okhla, New Delhi–110025.
South
DELHI |
9818327804
mwasimahmed.95@gov.in |
| DR MOHD MUDASSIR |
Regional Research Institute of Unani Medicine |
Research OPD Room Nazla(Common Cold), Chandbali Bypass Road, Near Rural Police Station, Bhadrak–756100
Bhadrak
ORISSA |
8383096715
mudassir.ccrum@ccrum.res.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Clinical Research Unit, Burhanpur |
Submittted/Under Review |
| Clinical Research Unit, Kerala |
Approved |
| Regional Research Institute of Unani Medicine, Bhadrak |
Approved |
| Regional Research Institute of Unani Medicine, Delhi |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00||Acute nasopharyngitis [common cold], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lauq-e-Nazli |
5gm orally with water after breakfast and dinner for 7 days. |
| Comparator Agent |
NIl |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of Nazla (Common Cold) presenting any of the following sign and symptoms:
1.Fever less than 100 F
2.Headache
3.Sneezing
4.Nasal irritation/ Nasal Itching
5.Redness of Face
6.Discharge of yellowish secretion of thin consistency
7.Sore throat/Khashunat e Halaq
8.Runny nose
|
|
| ExclusionCriteria |
| Details |
1. Known cases of Acute or Chronic lower respiratory tract infection like pneumonia, Bronchitis, Asthma and Bronchiectasis.
2. Fever more than 100 o F.
3. History of hepatic, renal disorders, diabetes mellitus, hypertension, or any other ailment needing long term therapy.
4. Known cases of any other acute illness.
5. Pregnant and lactating women.
6. History of Addiction (smoking, alcohol).
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The patients will be assessed by subjective and objective clinical observations which will be recorded in the follow-up sheet. |
At baseline and completion of the treatment. (i.e., 0 and 7th day) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pathological and biochemical investigations for safety assessment i.e., Hemogram, LFT, KFT and Urine routine microscopy. |
At baseline and completion of the treatment. (i.e., 0 and 7th 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)
|
18/08/2025 |
| 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 Nazla (common cold). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at baseline and completion of the treatment. (i.e., 0 and 7th day). This includes subjective assessment of general well being and physical examination. The total duration of treatment will be 07 days. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy (i.e., 0 and 7th day). Composition of Lauq-e-Nazli | S. No. | Ingredients | Scientific/Botanical Name | Quantity | | 1. | Tukhm-e-Khatmi | Althaea officinalis Linn | 25 gm | | 2. | Behidana | Cydonia oblonga Mill. | 25 gm | | 3. | Asl-us-Soos | Glycyrrhiza glabra Linn | 20 gm | | 4. | Khaskhaash Safaid | Papaver somniferum Linn | 20 gm | | 5. | Qand Safaid | Sugar, API Crystals | 500 gm | | 6. | Khaskhaash Siyah | Papaver somniferum Linn | 20 gm | | 7. | Samagh-e-Arabi | Acacia nilotica Linn | 10 gm | | 8. | Maghz-e-Behidana | Cydonia oblonga Mill | 10 gm | | 9. | Kateera | Cochlospermum religiosum Linn. | 15 gm | |