| CTRI Number |
CTRI/2025/09/094728 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| 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
|
A Clinical Study on Chronic Rhinosinusitis In Unani |
|
Scientific Title of Study
|
A Randomized Parallel Group Open Label Active Controlled Clinical Study to evaluate the Safety and Efficacy of Unani Formulations Joshanda (Oral) and Takmid Muhallil (Local) compared with Levocetirizine in the Management of Waram Tajawif al- Anf Muzmin (Chronic Rhinosinusitis) |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr NAEEM AHMED SHAIKH IBRAHIM |
| Designation |
P.G.Scholar |
| Affiliation |
National Research Institute of Unani Medicine For Skin Disorders |
| Address |
Department Of Moalajat, National Research Institute of Unani Medicine For Skin Disorders,A.G.Colony Road, Opp. E.S.I Hospital, Erragadda, Hyderabad, Telangana
Hyderabad
TELANGANA
500038
India |
| Phone |
7875579767 |
| Fax |
|
| Email |
naeem.sk14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arzeena Jabeen |
| Designation |
Principal & Professor |
| Affiliation |
National Research Institute of Unani Medicine For Skin Disorders |
| Address |
National Research Institute of Unani Medicine For Skin Disorders,A.G.Colony Road, Opp. E.S.I Hospital, Erragadda, Hyderabad, Telangana
Hyderabad
TELANGANA
500038
India |
| Phone |
9032519286 |
| Fax |
|
| Email |
aarzu763@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr NAEEM AHMED SHAIKH IBRAHIM |
| Designation |
P.G.Scholar |
| Affiliation |
National Research Institute of Unani Medicine For Skin Disorders |
| Address |
Department Of Moalajat, National Research Institute of Unani Medicine For Skin Disorders,A.G.Colony Road, Opp. E.S.I Hospital, Erragadda, Hyderabad, Telangana
Hyderabad
TELANGANA
500038
India |
| Phone |
7875579767 |
| Fax |
|
| Email |
naeem.sk14@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Research Institute of Unani Medicine For Skin Disorders, |
|
|
Primary Sponsor
|
| Name |
National Research Institute of Unani Medicine For Skin Disorders |
| Address |
A.G. Colony Road, Opp.E.S.I Hospital, Erragadda, Hyderabad, Telangana,500038 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| CCRUM |
New Delhi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Naeem Ahmed Shaikh Ibrahim |
National Research Institute of Unani Medicine for Skin Disorders |
Room no 2, OPD No 13 & IPD OF DEPARTMENT OF MOALAJAT,
NRIUMSD, A.G.Colony Road, Opposite E.S.I Hospital, Erragadda, 500038
Hyderabad
TELANGANA |
7875579767
naeem.sk14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics commitee , NRIUMSD, Hyderabad Telangana 500038 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J32||Chronic sinusitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1 Tablet: Levocetrizine Hydrochloride
2 Steam Inhalation ( Normal Water)
2 |
1 Levocetirizine Hydrochloride (Tablet, Oral)
Dosage Form And Route: Tablet, Oral
Dosage: One Tablet (10 Mg) Once Daily At Bed Time
Instructions: Take One Tablet Orally With Water At Bed Time.
Duration of Therapy: 42 days
2 Steam Inhalation (Normal Water)
Dosage Form And Route: Inhalation, Local
Dosage: Steam Inhalation With Normal Water Twice Daily
Duration of Therapy: 42 days
Instructions: Inhale Warm Steam From Normal Water Twice Daily |
| Intervention |
Unani Formulations -
1-Joshanda (Decoction Orally)
2- Takmid ( Hot Fomentation) |
1 Joshanda (Decoction, Oral)
Dosage Form And Route: Decoction,Oral
Dosage: 25 G Coarse Powder Twice Daily Before Meals
Duration of Therapy: 42 days
Composition: Gaozaban(Borago Officinalis L.) 3 G,
Gul Gaozaban (Borago Officinalis L. Flowers) 3 G, Unnab (Ziziphus Mauritiana Lam.) 5 Fruits,Asl Alsus Mulethi Chillihui (Glycyrrhiza Glabra L.) 5 G, Koya Abresham (Bombyx Mori L.) 5 G, Sabus Gandum Wheat Husk (Triticum Aestivum L.) 5 G, Misri Rock Sugar (Saccharum Officinarum L.) 24 G.
Method Of Use: Soak 25 G Powder In 200 Ml Water, Boil till One Third, Filter, Take Twice Daily.
2 Takmid Muhallil (Hot Fomentation, Local)
Dosage Form And Route: Coarse Powder Poultice, Local
Dosage: 36 G Powder In Poultice Twice Daily
Duration of Therapy: 42 days
Composition: Sabus Gandum (Triticum Aestivum L.) 24 G, Bajra (Pennisetum Glaucum L. R. Br.) 24 G, Namak Taam (Common Salt) 24 G.
Method Of Use: 36 G Powder Tied In Cloth, Warmed Lightly, Applied Locally Twice Daily.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1- Participants Of Either Gender Aged 18 To 60 Years
2- Participants Fulfilling AAO HNS (American Academy Of Otolaryngology Head And Neck Surgery) Criteria: Twelve Weeks Or Longer Of Two Or More Of The Following Signs And Symptoms:
a) Mucopurulent Drainage (Anterior, Posterior, Or Both)
b) Nasal Obstruction (Congestion)
C) Facial Pain, Pressure, Or Fullness
d) Decreased Sense Of Smell
e)Inflammation Documented By One Or More Of The Following:
i) Purulent (Not Clear) Mucus Or Edema In The Middle Meatus Or Anterior Ethmoid Region
ii) Polyps In Nasal Cavity Or Middle Meatus or Radiographic Imaging Showing Inflammation Of Paranasal Sinuses
3- Ability To Understand And Provide Written Informed Consent
4- Willingness To Attend Follow Up Visits As Per Protocol
|
|
| ExclusionCriteria |
| Details |
1 Age Below 18 Years Or Above 60 Years
2 Pregnant Or Lactating Women
3 Significant Pulmonary, Cardiovascular, Hepato Renal Dysfunctions Or Chronic Diseases Requiring Long Term Treatment
4 Known Cases Of Immunocompromised States Such As HIV Or AIDS
5 Known Hypersensitivity To Study Drug Or Any Of Its Ingredients |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1- Change In SNOT 22 Score From Baseline To 6 Weeks Of Treatment
2- Change In VAS Score From Baseline To 6 Weeks Of Treatment
|
2 and 4 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Evaluation Of Safety
1- By Monitoring Adverse Events Related To Either Unani Drug Or Control Drug Documented At Each Clinical Assessment Visit (Week 2, Week 4, Week 6) As Reported By Participants And Observed By Physician
2 Change In Radiological Findings Assessed By X Ray PNS (Waters View) From Baseline To End Of 6 Weeks Of Treatment
3- Change In Laboratory Parameters From Baseline To Week 6 Including:
Haemogram (Hb, TLC, DLC, RBC Count, Platelet Count, ESR)
Liver Function Tests (Serum Bilirubin, SGOT, SGPT, Serum Alkaline Phosphatase)
Kidney Function Tests (Serum Creatinine, Blood Urea)
4- Urine Examination (Routine And Microscopic)
|
2 and 4 Weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/01/2026 |
| 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 Yet Recruiting |
| 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
|
Chronic Rhinosinusitis (CRS) is a chronic inflammatory disease of the nasal and paranasal sinus mucosa persisting for more than 12 weeks. It is a common condition, affecting about 5–15 percent of the general population, with millions of cases reported annually in India. CRS is one of the leading causes of visits to primary care physicians and is among the top reasons for prescribing antibiotics. Although not life threatening, the condition significantly reduces quality of life due to persistent symptoms such as nasal obstruction, nasal discharge, facial pain or pressure, and loss of smell.
Maxillary sinus is most commonly involved, but pansinusitis may also occur. Complications include ear infections, orbital cellulitis, meningitis, brain abscess, and cavernous sinus thrombosis. Conventional medical management often involves prolonged use of antibiotics, antihistamines, nasal decongestants, steroids, and saline irrigation. These therapies are associated with adverse effects such as sedation, hepatotoxicity, rebound nasal congestion, and gastrointestinal disturbances. In non-responders, surgical procedures like Caldwell-Luc operation are used, but recurrence is common. Thus, there is no permanent cure, highlighting the need for alternative safe and effective options.
In Unani medicine, conditions resembling CRS are described under Nazla and Zukam. Classical Unani texts mention that chronic catarrhal discharges from the brain to nose and throat result in long-standing complaints. Management principles include hot fomentation (Takmid Har), steam inhalation (Inkibab), evacuation of morbid matter (Nuzj Mawad), removal of obstruction (Taftih Sudda), and strengthening of brain (Taqwiyat Dimagh).
Joshanda (oral decoction) and Takmid Muhallil (local hot fomentation) are compound Unani formulations recorded in Bayaz Kabir. They possess anti-inflammatory, antioxidant, antibacterial, antiallergic, analgesic, expectorant, and decongestant properties.
The present randomized, open label, parallel group, active controlled clinical Study has been planned to evaluate the safety and efficacy of these Unani formulations compared with Levocetirizine in the management of chronic rhinosinusitis. The study will assess improvement in symptoms, quality of life, radiological findings, and laboratory parameters to provide scientific validation of the Unani approach. |