| CTRI Number |
CTRI/2020/05/025388 [Registered on: 27/05/2020] Trial Registered Prospectively |
| Last Modified On: |
23/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Unani formulation (Joshanda) on Iltihab Tajawif al-Anf Muzmin (Chronic Sinusitis) |
|
Scientific Title of Study
|
A Clinical Study of the Effects of Unani Formulation (Joshanda) with Reference to the Standard Control in the Management of Iltihab Tajawif al-Anf Muzmin (Chronic Sinusitis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohd Tauseef Alam |
| Designation |
PG Scholar |
| Affiliation |
Regional Research Institute of Unani Medicine |
| Address |
Department of Moalajat, RRIUM, Naseem Bagh Campus University of Kashmir, Hazratbal
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
8791311019 |
| Fax |
|
| Email |
tauseef0690@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mohammad Sheeraz |
| Designation |
Lecturer |
| Affiliation |
Regional Research Institute of Unani Medicine |
| Address |
Department of Moalajat, RRIUM, Naseem Bagh Campus University of Kashmir, Hazratbal
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
9797750472 |
| Fax |
|
| Email |
sheeraz.rrium@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shameem Ahmad Rather |
| Designation |
Reader |
| Affiliation |
Regional Research Institute of Unani Medicine |
| Address |
Department of Moalajat, RRIUM, Naseem Bagh Campus University of Kashmir, Hazratbal
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
7889584083 |
| Fax |
|
| Email |
Shameem.rather.sr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central council for Research in Unani Medicine New Delhi |
|
|
Primary Sponsor
|
| Name |
Central council for Research in Unani Medicine New Delhi |
| Address |
Regional Research Institute of Unani Medicine (RRIUM),
University of Kashmir, Srinagar. CCRUM, New Delhi. |
| Type of Sponsor |
Research institution |
|
|
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 |
| Mohd Tauseef Alam |
Regional Research Institute of Unani Medicine (RRIUM). |
Moalajat OPD-2, Ground Floor, Dept. of Moalajat, RRIUM, Naseem Bagh Campus University of Kashmir, Hazratbal
Srinagar
JAMMU & KASHMIR |
8791311019
tauseef0690@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, RRIUM, Srinagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J329||Chronic sinusitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Joshanda (Decoction) of Nuskha Nazla barid
|
Ingredients : Gul-e-banfsha (7gm), Tukhm-e-Khatmi (7gm), Tukhm-e-khubazi (7gm), Barg-e-Gaozaban (5gm), Unnab (5 in numbers), Misri (20gm).
Method of preparation: Joshanda (Decoction) of the all ingredients will be prepared as per standard procedure.
Dose: 100 ml.
Frequency: Twice daily before meal.
Route of administration: Oral. Duration of therapy: 45 days |
| Intervention |
Joshanda (Decoction) of Unani Formulation |
Ingredients: Badiyan (4.5gm),
Banafshan (4.5gm),
Hansraj (4.5gm),
Asl-us-soos (4.5gm),
Gaozaban (4.5gm),
Sapistan (15 in number), Maveez munaqqa (15 in number), Misri (18gm).
Method of preparation: Joshanda (Decoction) of the all ingredients will be prepared as per standard procedure.
Dose: 100 ml.
Frequency: Once a day early in the morning before meal.
Route of administration: Oral.
Duration of therapy: 45 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
-Clinically diagnosed patients of chronic sinusitis of more than 12 weeks duration.
-Patients Irrespective of gender.
-Patients in the age group of 20-60 years.
-SNOT 22 (Sinonasal Obstruction Test) more than 7.
-Patients who have agreed to sign the informed consent form and follow up the protocol
|
|
| ExclusionCriteria |
| Details |
-Subjects below the age of 20 years and above the age of 60 years
-Atrophic rhinitis.
-Deviated Nasal Septum.
-Nasal polyps / Nasal growth / Adenoids.
-Patients with systemic diseases like diabetes, cardiovascular, impaired renal and hepatic functions, HIV, T.B., COPD.
-Patients who refuse to give the written consent for the study.
-Pregnancy and lactating women.
-Any of them not covered under inclusive criteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in signs and symptoms of Chronic sinusitis (Nazla Barid) |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical assessment for safety |
45 days |
|
|
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 |
|
Date of First Enrollment (India)
|
28/05/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Sinusitis is inflammation of the sinus or nasal passage . It is classified as acute and chronic sinusitis. Sinusitis is also called Rhinosinusitis . Chronic sinusitis is chronic inflammation of the sinus or nasal passage occurring for more than 12 weeks at a time or ( chronic rhinosinusitis is defined as more than 12 weeks of symptoms without complete resolution of symptoms and can be subdivided into chronic sinusitis with nasal polyp and without nasal polyp. It is a specific clinical symptoms complex. Approximately 20% of the patients with chronic sinusitis have nasal polyposis. Chronic rhinosinusitis affects approx 5-15% of the general population. The prevalence was found to be 2-4%. According to the national health interview survey of 1996 chronic rhinosinusitis was second most prevalent health condition affecting 12.5% of the US population or 31 million patients each year. Affecting individual of all ages.There are no racial differences in prevalence but the presence of nasal polyps’ increases with age and more commonly found in men.Acute viral sinusitis is the most common cause of chronic sinusitis. According to an analysis of the 2008 National Health interview survey data, rhinosinusitis affected 1 in 7 adults. The symptoms of chronic sinusitis include purulent nasal discharge, Constant sinus pressure, chronic cough, halitosis. Since chronic rhinosinusitis is not fatal disease but its outcome is orbital cellulitis, subperiosteal abscess, cavernous sinus thrombosis, brain abscess etc. In Unani system of medicine sinusitis is not described as such but when we go through the definitions of Nazla wa Zukam these seem to be quite similar to the clinical feature of sinusitis. Medical therapy is effective in reducing the symptoms but allopathic medicines do have various side effects. Unani physicians are treating the symptoms of sinusitis for centuries with safe herbal remedies. Need of the hour is to validate these safe drugs scientifically. So, in order to provide safe and effective drug for chronic sinusitis, the present study is therefore designed at investigating the effect of Unani formulation on chronic sinusitis patients. |