| CTRI Number |
CTRI/2026/03/105629 [Registered on: 09/03/2026] Trial Registered Prospectively |
| Last Modified On: |
06/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Jadwar in People with Chronic Sinusitis |
|
Scientific Title of Study
|
A Controlled Clinical Study to Evaluate the Safety and Efficacy of Jadwar (Delphinium denudatum) in the Management of Chronic Sinusitis |
| 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 Shoaib Khan |
| Designation |
Research Scholar |
| Affiliation |
Jamia Hamdard |
| Address |
Department of Moalajat, School of Unani Medical Education and Research, Jamia Hamdard, New Delhi
South
DELHI
110062
India |
| Phone |
7565882213 |
| Fax |
|
| Email |
shoaibkhan.ar079@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Md Anzar Alam |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Hamdard |
| Address |
Department of Moalajat, School of Unani Medical Education and Research, Jamia Hamdard, New Delhi
South
DELHI
110062
India |
| Phone |
9916164662 |
| Fax |
|
| Email |
dranzaralam@jamiahamdard.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shoaib Khan |
| Designation |
Research Scholar |
| Affiliation |
Jamia Hamdard |
| Address |
Department of Moalajat, School of Unani Medical Education and Research, Jamia Hamdard, New Delhi
South
DELHI
110062
India |
| Phone |
7565882213 |
| Fax |
|
| Email |
shoaibkhan.ar079@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jamia Hamdard (Deemed to be University), Hamdard Nagar, New Delhi, Delhi, India - 110062 |
|
|
Primary Sponsor
|
| Name |
Jamia Hamdard University |
| Address |
Department of Moalajat, School of Unani Medical Education and
Research, Jamia Hamdard, Hamdard Nagar, New Delhi, Delhi, India - 110062 |
| 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 Shoaib Khan |
Majeedia Unani Hospital, Jamia Hamdard |
Room no. 7, OPD Of Moalajat, Majeedia Unani Hospital, School of Unani Medical
Education and Research, Jamia Hamdard, Hamdard Nagar, New Delhi, Delhi, India
- 110062
South
DELHI |
7565882213
shoaibkhan.ar079@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jamia Hamdard Institutional Ethical Committee |
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 |
| Intervention |
jadwar (Delphinium denudatum) |
The intervention group will receive Jadwar (Delphinium denudatum) in capsule form at a dose of 500 mg, administered orally twice daily with lukewarm water for 30 days |
| Comparator Agent |
placebo |
Placebo capsule (500 mg) containing an inert substance, identical to the intervention drug, administered orally twice daily with lukewarm water for 30 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 18 and 60 years of either gender.
Clinically diagnosed cases of chronic sinusitis confirmed by nasal endoscopy and/or radiological imaging.
Patients experiencing symptoms such as nasal congestion, facial pain or pressure, headache, or post-nasal drip persisting for at least 4 weeks.
Patients who are willing to provide written informed consent and comply with the study protocol and follow-up schedule. |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women.
Patients with a history of recent nasal or sinus surgery.
Patients suffering from any major systemic disorder.
Patients with immunocompromised conditions such as HIV or tuberculosis.
Patients who have used corticosteroids, antibiotics, or other treatments for sinusitis within the past four weeks.
Patients with nasal polyps or significant sinonasal structural abnormalities (e.g., markedly deviated nasal septum). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in total SNOT-22 (Sino-Nasal Outcome Test-22) score in patients with chronic sinusitis treated with Jadwar. |
Baseline (Day 0) and Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in quality of life assessed by SF-12 questionnaire. |
Baseline (Day 0) and Day 30 |
|
|
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 |
|
Date of First Enrollment (India)
|
30/03/2026 |
| 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="0"
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
|
Chronic sinusitis is a common inflammatory condition of the paranasal sinuses persisting for more than 12 weeks and significantly affecting patients’ quality of life. Conventional treatments such as antihistamines, corticosteroids, antibiotics, and decongestants provide symptomatic relief but are often associated with adverse effects, especially with prolonged use. In Unani medicine, chronic sinusitis (Waram Tajaweef-e-Anf Muzmin) is attributed to humoral imbalance and Su’-e-Mizaj. Jadwar (Delphinium denudatum) is a well-known Unani single drug traditionally used for respiratory and inflammatory conditions due to its anti-inflammatory, analgesic, and neuroprotective properties. However, scientific clinical validation of its efficacy in chronic sinusitis remains limited. The present study is a randomized, single-blind, placebo-controlled clinical trial designed to evaluate the safety and efficacy of Jadwar in patients with chronic sinusitis. A total of 60 eligible participants aged 18-60 years will be randomly allocated into two groups: Group A (Jadwar 500 mg capsule twice daily) and Group B (placebo) for 30 days. The primary outcome will be assessed using change in SNOT-22 score, and the secondary outcome will include quality of life assessment using SF-12 questionnaire. Safety will be evaluated through laboratory investigations and monitoring of adverse events. The study aims to provide scientific evidence for the therapeutic role of Jadwar in the management of chronic sinusitis. |