| 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
|
|
|
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
|
|
|
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 HÄrr (Allergic Rhinitis) To Evaluate the Efficacy of La„ūq RummÄn in It‟s management†is contemplated to evaluate the efficacy of La‘ūq RummÄn with the objective of improvement in symptoms and quality of life of the sufferers of Allergic Rhinitis. |