| CTRI Number |
CTRI/2015/02/005526 [Registered on: 11/02/2015] Trial Registered Retrospectively |
| Last Modified On: |
03/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the Safety and efficacy of Unani formulations in the treatment of Dry Cough |
|
Scientific Title of Study
|
Clinical Validation of Unani Pharmocopoeial Formulation Sharbat Ejaz in Surfa YÄbis (Dry Cough) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SY/DC/SE CLNVAL/CCRUM 13-14 VERSION 1 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PROF S SHAKIR JAMIL |
| Designation |
DIRECTOR GENERAL |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
West
DELHI
110058
India |
| Phone |
01128521981 |
| Fax |
01128522965 |
| Email |
unanimedicine@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR K M Siddiqui |
| Designation |
ASSISTANT DIRECTOR SCIENTIST IV |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
West
DELHI
110058
India |
| Phone |
9810161758 |
| Fax |
01128522965 |
| Email |
ccrum507@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Kumar |
| Designation |
RESEARCH OFFICER SCIENTIST III |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
West
DELHI
110058
India |
| Phone |
01128521981 |
| Fax |
01128522965 |
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support : 1.Regional Research Institute of Unani Medicine(RRIUM), New Delhi 2.Regional Research Institute of Unani Medicine (RRIUM), Mumbai3. Regional Research Institute of Unani Medicine (RRIUM), Srinagar
4.Clinical Research Unit (CRU), Meerut
Monetary Support : Central Council for Research in Unani Medicine (CCRUM), New Delhi
|
|
|
Primary Sponsor
|
| Name |
Monetary Support Central Council for Research in Unani Medicine CCRUM New Delhi |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058. |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR MOHD TARIQ KHAN |
Clinical Research Unit, Meerut |
Gulzar-e- Ibrahim, Gali No. 2, Tanki Wali Gali, Bhomiya Ka Pul, lesari Road
Meerut
UTTAR PRADESH |
09012843253
doctormtk@gmail.com |
| DR IRFAN AHMAD |
Regional Research Institute of Unani Medicine (RRIUM), Mumbai |
J. J. Hospital Campus Behind Eye Bank, Byculla,
Mumbai
MAHARASHTRA |
02223742173
rrium.mumbai@gmail.com |
| DR SALMA KHATOON |
Regional Research Institute of Unani Medicine(RRIUM), New Delhi |
D-11, Abul Fazal Enclave, Jamia Nagar, New Delhi-25
South
DELHI |
01126952759
rriumdelhi@gmail.com |
| DR HUMA |
Regional Research Institute of Unani Medicine(RRIUM), Srinagar |
Naseem Bagh Campus, University of Kashmir
Srinagar
JAMMU & KASHMIR |
01942414604
rrium.srinagar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Regional Research Institute of Unani Medicine(RRIUM), Srinagar |
Approved |
| Clinical Research Unit, Meerut |
Approved |
| Regional Research Institute of Unani Medicine (RRIUM), Mumbai |
Approved |
| Regional Research Institute of Unani Medicine(RRIUM), New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R05||Cough, Surfa YÄbis (Dry Cough), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
na |
| Intervention |
Sharbat Ejaz |
Dose :Sharbat Ejaz (Syrup)20 ml BD Orally mixed with 40 ml of Lukewarm water for two weeks
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
• Patients of either sex in the age group of 18-60
• Surfa YÄbis (Dry Cough) of < 3 weeks duration
|
|
| ExclusionCriteria |
| Details |
•Upper Respiratory Tract Infections (URI or URTI) including rhinitis, rhinosinusitis or sinusitis, nasopharyngitis (rhinopharyngitis or common cold), pharyngitis tonsillitis, epiglottitis (supraglottitis), laryngitis, laryngotracheitis, tracheitis, and otitis media.
•Lower Respiratory Tract Infections (LRI or LRTI) including pneumonia, lung abscess, and acute bronchitis.
•Chronic obstructive airway disease (COAD) including chronic bronchitis and emphysema.
•Bronchiectasis, pulmonary tuberculosis, pulmonary oedema, interstitial pulmonary fibrosis
•Tumours of larynx, bronchi, and lungs
•Drug-induced Cough (e.g., ACE Inhibitors)
•Diabetes Mellitus, Hypertension
•Known cases of severe hepatic, renal or cardiac ailments
•H/o addiction (smoking, alcohol, drugs)
•Pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in signs and symptoms |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hematological and biochemical assessments for safety |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
01/02/2014 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is designed as a multicentric open trial in patients with Surfa YÄbis (Dry Cough) After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically every week. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 02 weeks. . Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
Composition
of Sharbat Ejaz
|
S.
No.
|
Ingredients
|
Botanical
/ Chemical Name
|
Quantity
|
|
1.
|
Barg-e-Arusa
|
Adhatoda vasica
|
500 g
|
|
2.
|
Unnab
|
Zyzifus
sativa
|
50 g
|
|
3.
|
Sapistan
|
Cordia
latifolia
|
50 g
|
|
4.
|
Asl-us-Soos
|
Glycyrrhiza glabra
|
25 g
|
|
5.
|
Tukhm-e-Khatmi
|
Althaea
officinalis
|
25 g
|
|
6.
|
Tukhm-e-Khubazi
|
Malva sylvestris
|
25 g
|
|
7.
|
Gul-e-Neelofar
|
Nymphaea
alba
|
25 g
|
|
8.
|
Gul-e-Banafsha
|
Viola
odorata
|
25 g
|
|
9.
|
Behidana
|
Cydonia oblonga
|
20 g
|
|
10.
|
Kateera
|
Astragalus
gummifer
|
10 g
|
|
11.
|
Samag-e-Arabi
|
Acacia
arabica
|
10 g
|
|
12.
|
Qand Safaid
|
Saccharaum officinale
|
1 kg
|
|
13.
|
Aab
|
Oxidane (Water)
|
Q.S.
|
|