| CTRI Number |
CTRI/2023/03/050913 [Registered on: 21/03/2023] Trial Registered Prospectively |
| Last Modified On: |
20/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical comparative efficacy and safety of Polyherbal Unani formulations. |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Efficacy and
Safety of Polyherbal Unani formulations in
the management of IltihÄb TajÄwÄ«f- al-Anf
Muzmin (Chronic Rhinosinusitis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ruvaida Parveen |
| Designation |
PG scholar |
| Affiliation |
State Unani Medical College, Himmatganj, Prayagraj-211016 |
| Address |
Department of Amraze Ain Uzn Anf Halaq Wa Asnan, State Unani Medical College Himmatganj Prayagraj- 211016
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
9621216373 |
| Fax |
|
| Email |
Ruvaidaparveen524@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 Prayagraj |
| Address |
Department of Amraze Ain Uzn Anf Halaq Wa Asnan, State Unani Medical College Himmatganj Prayagraj- 211016
Allahabad
UTTAR PRADESH
211001
India |
| Phone |
7905831926 |
| Fax |
|
| Email |
asifhussainusmani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Usamah Ahmad |
| Designation |
Associate Professor |
| Affiliation |
State Unani Medical College Prayagraj |
| Address |
Department of Amraze Ain Uzn Anf Halaq Wa Asnan, State Unani Medical College Himmatganj Prayagraj- 211016
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
9415639877 |
| Fax |
|
| Email |
Arogyaherbal@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Unani Medical College Himmatganj,Prayagraj 211016, Ministry of AYUSH, U.P govt. |
|
|
Primary Sponsor
|
| Name |
State Unani Medical College, himmatganj Prayagraj |
| Address |
Department of Amraze Ain Uzn Anf Halaq wa Asnan, State Unani
Medical College, himmatganj Prayagraj 211016 India |
| 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 |
| Ruvaida parveen |
OPD/IPD of Ain, Uzn, Anf, Halaq wa Asnan State Unani Medical College and hospital |
State Unani medical college and hospital himmatganj prayagraj
Allahabad
UTTAR PRADESH |
9621216373
Ruvaidaparveen524@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J39||Other diseases of upper respiratory tract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
polyherbal Unani joshanda ( decoction) 20ml twice a day (Oral) for 28days
InkibÄb (Steam Inhalation) (local) for 28days |
polyherbal Unani joshanda ( decoction) of Asl-al-SÅ«s (Glycyrrhiza glabra L.) 5 gm
and Barg-i- GÄozabÄn (Borago officinalis L.) 5 gm 20ml twice a day (oral)
InkibÄb (Steam Inhalation) of SabÅ«s Gandum (Wheat husk) 7 gm SirkÄ (Vinegar) 20 mL Ä€b (Water) 100 mL (local)
For 28days |
| Comparator Agent |
Tab Levocetirizine hydrochloride 10mg Once a day (Oral)
Simple Steam inhalation (local) |
Tab Levocetirizine hydrochloride
Dose: 10 mg once a day orally with water at night
Simple Steam inhalation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
The following patients will be included
1 More than twelve weeks of persistent symptoms of rhinosinusitis
2 X ray PNS Waters view shows haziness or opacity and may show free fluid level in affected sinus
3 Those are signed on the consent paper and ready to follow protocol
4 Patient age within the range of 18 to 60 years
5 Both the gender Male & Female
|
|
| ExclusionCriteria |
| Details |
The following patients will be excluded:
1 Patient’s age below 18 years and above 60 years
2 Pregnant and Lactating women
3 Nasal polyp, deviated nasal septum, mucocele, cyst, antrochoanal polyp,
facial trauma
4 Significant Pulmonary/ Cardiovascular/ Hepato-renal dysfunctions
5 Known cases of immunocompromised states (HIV, AIDS etc.)
6 Patients not willing to attend treatment schedule regularly |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
the response to treatment will be assessed using the following parameters
X-ray PNS
CSAS (chronic sinusitis assessment score) |
Clinical assessment will be done at 0,1,2,3,4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| CSAS (chronic sinusitis assessment score |
10th,20th dat |
|
|
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)
|
25/03/2023 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
IltihÄb TajÄwÄ«f -al-Anf (Sinusitis) is the mucosal inflammation
of the paranasal sinuses1
. However, as this condition is invariably associated with
inflammation of the nasal mucosa. Hence, nowadays the term Rhinosinusitis (RS)
has been preferred. Rhinosinusitis is of two types - acute and chronic. Chronic
rhinosinusitis is chronic inflammatory disease of nasal and paranasal sinus mucosa
where symptomatology has continued beyond 12 weeks . Rhinosinusitis affects a
tremendous proportion of the population, accounts for millions of visits to primary
care physicians each year and is the fifth leading diagnosis for which antibiotics are
prescribed . Chronic inflammation of the sinus mucosa is a common disease.
Chronic rhinosinusitis is usually the result of incompletely resolved acute
rhinosinusitis . The maxillary sinus is the most commonly involved paranasal sinus in
chronic rhinosinusitis. However, the inflammation of the other sinuses is not
uncommon and sometimes all the sinuses are involved, resulting in pansinusitis.
Chronic rhinosinusitis affects approximately 5–15% of the general population. The national institute of allergy and infectious disease (NIAID) estimated that
about 134 million Indians suffered from chronic rhinosinusitis. The symptoms of
chronic rhinosinusitis are not life threatening but they are associated with the
reduction in quality of life7
. Rhinosinusitis typically causes a combination of nasal
congestion, nasal blockage, nasal discharge and may be accompanied by facial pain
or pressure and loss of smell (anosmia). Pain is aggravated on stooping or
coughing . Complications of chronic rhinosinusitis are deafness, tinnitus,
osteomyelitis, orbital abscess, orbital cellulitis, meningitis, brain abscess, subdural
abscess, extradural abscess, cavernous sinus thrombosis, acute suppurative otitis
media, chronic suppurative otitis media, pharyngitis, tonsillitis, persistent laryngitis
and tracheobronchitis. Medical management of chronic rhinosinusitis often
requires multiple medications including antibiotics, antihistamines, nasal
decongestants, topical or oral steroids and saline irrigation. Antibiotics causes
several side effects such as Cushing syndrome, abdominal tenderness, bloating,
cramps, diarrhoea, epistaxis, haematuria etc. Antihistaminic side effects are
mydriasis, sedation, dry eyes, dry mouth, constipation, and urinary retention.
Significant overdose of antihistamines can cause serious toxicity and even death.
Levocetirizines leads to mild sedation, somnolence, dry mouth and in some patient
hepatotoxicity noticed . Fexofenadine is not safe in patient with long QT interval,
bradycardia and hypokalemia. Nasal decongestants like oxymetazoline and
xylometazoline cannot give for more than 5 days because of the potential for
rebound congestion and rhinitis medica mentosa . Patient who does not respond to
medical treatment requires surgical treatment (Caldwell-Luc operation). There is no
solution for permanent relief and need an alternative approach which is effective
and safe. There are many single as well as compound Unani drugs which are
effective in chronic rhinosinusitis but many of them have not been evaluated
clinically on scientific parameters. The limitation of management of chronic
rhinosinusitis available in modern medicine necessitate a scientific search for
effective, safe and convenient medication for the disease. Keeping this in view, the
present study is designed to evaluate the efficacy and safety of polyherbal Unani
formulations in the form of JoshÄnda (decoction) of Asl-al-SÅ«s, Barg-i-GÄozabÄn
and along with InkibÄb (steam Inhalation) of Sabus Gandum (wheat husk) and SirkÄ
(vinegar) in case of chronic rhinosinusitis10,15,16,17,18
. Pharmacological action of
these Unani formulations are anti-inflammatory, analgesics, neurotronic and nasal
decongestant |