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CTRI Number  CTRI/2024/09/073459 [Registered on: 05/09/2024] Trial Registered Prospectively
Last Modified On: 01/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Single Arm Study 
Public Title of Study   Effectiveness of Lauq Rumman in the treatment of Nazla Harr (Allergic Rhinitis) 
Scientific Title of Study   A Clinical Study of Nazla Harr (Allergic Rhinitis) to Evaluate the Efficacy of Lauq Rumman in its Management 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Muzammil Husain 
Designation  P.G. Scholar 
Affiliation  State Unani Medical College, Himmatganj, Prayagraj, Uttar Pradesh. 
Address  Department of Amraze Ain, Uzn, Anf, Halaq wa Asnan, State Unani Medical College, Himmatganj, Prayagraj, Uttar Pradesh.

Allahabad
UTTAR PRADESH
211016
India 
Phone  7292038786  
Fax    
Email  muzammilhusainhamdani@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mohd Asif Hussain Usmani 
Designation  Professor and Head of the Department 
Affiliation  State Unani Medical College, Himmatganj, Prayagraj, Uttar Pradesh. 
Address  Department of Amraze Ain, Uzn, Anf, Halaq wa Asnan, State Unani Medical College, Himmatganj, Prayagraj, Uttar Pradesh.

Allahabad
UTTAR PRADESH
211016
India 
Phone  7905831926  
Fax    
Email  asifhussainusmani@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Usamah Ahmad 
Designation  Reader 
Affiliation  State Unani Medical College, Himmatganj, Prayagraj, Uttar Pradesh. 
Address  Department of Amraze Ain, Uzn, Anf, Halaq wa Asnan, State Unani Medical College, Himmatganj, Prayagraj, Uttar Pradesh.

Allahabad
UTTAR PRADESH
211016
India 
Phone  9415639877  
Fax    
Email  arogyaherbal@gmail.com  
 
Source of Monetary or Material Support  
State Unani Medical College and HAHRDM Hospital, Prayagraj, Uttar Pradesh, India, 211016  
 
Primary Sponsor  
Name  State Unani Medical College and HAHRDM Hospital 
Address  Himmatganj, Prayagraj, Uttar Pradesh, India, 211016 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Muzammil Husain  State Unani Medical College and HAHRDM Hospital  IPD/OPD of Department of Amraze Ain, Uzn, Anf, Halaq Wa Asnan, SUMC and HAHRDM Hospital, Himmatganj, Prayagraj, India, 211016.
Allahabad
UTTAR PRADESH 
7292038786

muzammilhusainhamdani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J309||Allergic rhinitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Lauq Rumman  Patients will be provided the study drug Lauq Rumman 10gm orally thrice daily with lukewarm water for 21 days. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Age between 18 50 years
2. Both gender
3. Symptoms persisted for more than 4 days per week or more than 4 weeks per year and at least one of the following rhinitis associated conditions: nasal congestion, rhinorrhea, sneezing and nasal itching
4. Patients who will give consent and able to do follow up 
 
ExclusionCriteria 
Details  1. Patients suffering from systemic illness like Hypertension, DM, Malignancy, Liver or Kidney dysfunction
2. Patients suffering from congenital nasal abnormalities like nasal dermoid cysts, congenital midline nasal masses, Deviated Nasal Septum, Atrophic rhinitis, Sinusitis, Hypertrophic turbinates, Adenoidal hypertrophy, foreign bodies or Asthma
3. Patients below 18 and above 50 years
4. Patients with past history of nose surgery
5. Patients had received systematically administered corticosteroids, antihistamines, decongestants or CAM therapy within 02 weeks prior to enrolment
6. Pregnant and lactating women 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Changes in Total Nasal Symptom Score (TNSS) and
2. Allergic Rhinitis Control Test (ARCT) 
Day 7, 14 and 21. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Improvement in Mini Rhino conjunctivitis Quality of Life Questionnaire (Mini RQLQ)
2. AEC( Absolute Eosinophilc Count ) 
Day 7, 14 and 21. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   12/09/2024 
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  
Allergic Rhinitis is an IgE mediated immunologic response of nasal mucosa to airborne allergens and is characterized by watery nasal discharge, nasal obstruction, sneezing and itching in the nose. This may also be associated with symptoms of itching in the eyes, palate and pharynx. It is estimated that AR currently affects up to 40% of the worldwide population, and high prevalence is being recorded in developed countries. Worldwide prevalence is sharply rising as more nations adopt western lifestyles. AR is thought to affect 500 million individuals worldwide, with the second decade of life seeing the highest occurrence. In India, reported incidence ranges between 20% and 30% with increasing prevalence over past few years.
According to the Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines, AR management encompasses allergen avoidance, pharmacotherapy (including intranasal corticosteroid and new second generation oral H1 antihistamines), immunotherapy and patient education. These treatments frequently have unfavorable side effects, are not always cost effective, and do not always completely relieve symptoms. Anaphylactic reactions, either local or systemic, can also result after immunotherapy.
Although AR is often considered a benign condition, it negatively impacts the quality of life (QOL) of affected individuals by impairing sleep quality and cognitive function, behavior, work performance and causing irritability, fatigue and anxiety with economic costs. Annual direct medical costs of AR are substantial, but indirect costs associated with lost work productivity are greater than those incurred by asthma.
Therefore, a safe and long--term effective treatment modality for AR is needed to provide symptom relief, decrease frequency and severity of AR recurrence and prevent the condition from progressing.
In Unani medicine, Allergic Rhinitis is treated by using Oral medicines (such as Behidana, Unnab, Sapistan, Banafsha, Kishneez, Asl--us--soos, Katira, Khatmi, Gaozaban etc.), Is’haal, Roghaniyaat either alone or in combination with Hijamat, Fasd, Qai’, Inkebab, Ghargharah, Takmeed, Nutool and Pashoya. Pharmacological studies suggest that these drugs contain pectins, mucilage, flavonoids, scopoletin, codein, polyphenols and possess anti--inflammatory, bronchodilator, anti--allergic, astringent, demulcent, expectorant, mild laxative, anti--tussive and immuno modulatory activity.
Therefore, a clinical trial entitled “A Clinical Study of Nazla Hārr (Allergic Rhinitis) To Evaluate the Efficacy of La„ūq Rummān in It‟s management” is contemplated to evaluate the efficacy of La‘ūq Rummān with the objective of improvement in symptoms and quality of life of the sufferers of Allergic Rhinitis.
 
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