| CTRI Number |
CTRI/2018/05/014151 [Registered on: 25/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
19/05/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Clinical trial of Unani coded formulations in cases of sinusitis |
|
Scientific Title of Study
|
Comparative therapeutic evaluation of unani coded formulations with and without Munzij & Munshil Therapy in cases of Sinusitis (Iltehab-e-Tajaweef-e-Anaf)
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ITA/SIN/CRIUM/2008 Version-2 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Musheer Ahmed |
| Designation |
Research Officer (Unani) |
| Affiliation |
Central Research Institute of Unani Medicine |
| Address |
8-3-168/A/1/UM, A.G Colony Road, Erragadda Hyderabad
Hyderabad
ANDHRA PRADESH
500038
India |
| Phone |
9848716693 |
| Fax |
|
| Email |
drmusheercrium@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Syed Gulnawaz Ahmad |
| Designation |
Research Officer (Unani) |
| Affiliation |
Central Research Institute of Unani Medicine |
| Address |
8-3-168/A/1/UM, A.G Colony Road, Erragadda Hyderabad
Hyderabad
ANDHRA PRADESH
500038
India |
| Phone |
9848716693 |
| Fax |
|
| Email |
skgulnawaz@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arzeena Jabeen |
| Designation |
Co Investigator |
| Affiliation |
Central Research Institute of Unani Medicine |
| Address |
8-3-168/A/1/UM, A.G Colony Road, Erragadda Hyderabad
Hyderabad
ANDHRA PRADESH
500038
India |
| Phone |
9032519286 |
| Fax |
|
| Email |
aarzu763@gmail.com |
|
|
Source of Monetary or Material Support
|
| Director General, Central Council for Research in Unani Medicine, Ministry of AYUSH |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine |
| Address |
61-65, Institutional Area, Opp. D-Block, Janakpuri, New Delhi, Delhi 110058 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Musheer Ahmed |
Central Research Institute of Unani Medicine |
Room no - 19, ROPD Unit-2, 8-3-168/A/1/UM, A.Gs Colony Road,
Hyderabad
ANDHRA PRADESH |
9848716693
drmusheercrium@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Approved by Ethics committee of CCRUM and amended by CRIUM EC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
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|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Sinusitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group B: UNIM 054 (Oral) and UNIM 055 (Vapours) with Munzij Mushil Therapy |
Patients are admitted in the In-Patient department for 30-40 days.200ml of the Munzij (coctive) drug was given on empty stomach early in the morning every day till the Nuzj appeared in the urine. After the completion of Munzij course, Mushil (purgative) drug and Tabreed (cooling drug) were given on alternate days for three days each. After completion of above therapies patients are shifted to OPD for further treatment.
UNIM 054 500mg tablet given orally twice daily
UNIM 055 , 1-2 drops to be poured in hot water and vapours inhaled as and when required.
Duration of therapy: 3 months |
| Intervention |
Group A: UNIM 054 (tab) and UNIM 055 (vapours) |
UNIM 054 500mg tablet given orally twice daily
UNIM 055 vapours adviced twice daily to be inhaled with hot water.
Duration of therapy: 3 months |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with radiologically confirmed sinusitis
Presence of any one of the signs and symptoms:
1. Nasal discharge
2. Sneezing
3. Headache
4. Nasal obstruction,
5. Malaise
6. Deviated and hypertrophied nasal septum |
|
| ExclusionCriteria |
| Details |
1. patients with PAN sinusitis
2. Hepato renal, cardio pulmonary disorders
3. Pregnant and lactating women
4. those on oral contraceptives
5. those on active treatment from other systems of medicine |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Efficacy evaluations:
Radiological clearance of sinuses.
2. improvement in the following signs and symptoms: Nasal discharge, sneezing, headache, nasal obstruction, malaise.
Safety evaluations:
clinical laboratory tests: LFT, RFT, AE/ ADR reporting |
Baseline, 15th days, 30th days, 45th days, 60th days, 90th days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety measures pathological and biochemical investigations |
Before and after treatment |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/10/2008 |
| Date of Study Completion (India) |
26/12/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="8"
Months="2"
Days="4" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Sinusitis is a clinical condition which is globally prevalent and affects large population in all age groups. The treatment in conventional modern system of medicine mostly consists of antibiotics, anti histemenic and decongestants which does not cure all, necessitating surgical interventions in good no. of patients which too does not provide complete and irreversible relief. hence it is of paramount importance to search new and safe therapies for the effective management of this disease. Ancient unani physicians have been treating different types of nazla including nazla-e-barid- muzmin. The symptomatology of which corresponds to sinusitis. Keeping this in view the present study has been planned and the trial drugs have proved safe and efficacious in the management of this disease. |