| CTRI Number |
CTRI/2021/12/038808 [Registered on: 21/12/2021] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Sual-e-Yabis (Dry Cough) with Unani medicine Habb-e-Luab-e-Behidana |
|
Scientific Title of Study
|
An open-label, Multicentric Clinical Validation Study to Evaluate the Efficacy and Safety of Unani Pharmacopoeial formulation – Habb-e-Luab-e-Behidana in Sual-e-Yabis (Dry Cough) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SY/DC/HLB/CLNVAL/CCRUM 19-20 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Asim Ali Khan |
| 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
South West
DELHI
110058
India |
| Phone |
01128525715 |
| Fax |
|
| Email |
unanimedicine@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naheed Parveen |
| Designation |
Assistant Director |
| 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
South West
DELHI
110058
India |
| Phone |
9213511298 |
| Fax |
|
| Email |
ccrum507@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Kumar |
| Designation |
Research Officer (Pathology) S-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
South West
DELHI
110058
India |
| Phone |
8800263300 |
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support : 1 Clinical Research Unit, Meerut
2. Regional Research Centre, Allahabad Monetary Support : Central Council for Research in Unani Medicine (CCRUM), New Delhi |
|
|
Primary Sponsor
|
| Name |
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 = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohd Naseem |
Clinical Research Unit (CRU), Meerut |
Research OPD Room,Sual-e-Yabis (Dry Cough), Cantonment General Hospital,Begum Bridge, Meerut
Meerut
UTTAR PRADESH |
8451934661
naseemrrium786@gmail.com |
| Dr Mohd Ehsan Ansari |
Regional Research Centre, Allahabad |
Research OPD Room,Sual-e-Yabis (Dry Cough),B-501/4, G.T.B Nagar (Opposite Dulhan Palace)
Allahabad
UTTAR PRADESH |
8887801120
dr.mehsan.ansari786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Clinical Research Unit, Meerut |
Approved |
| Regional Research Centre, Allahabad |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R05||Cough, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Habb-e-Luab-e-Behidana |
1 pill (250 mg) twice daily to be taken with warm water for two weeks |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex in the age group of 18-60 years.
2. Sual-e-Yabis (Dry Cough) of < 3 weeks duration |
|
| ExclusionCriteria |
| Details |
1. Acute Upper Respiratory Tract Infections (URI or URTI)
2. Acute Lower Respiratory Tract Infections (LRI or LRTI) including pneumonia, lung abscess, and acute bronchitis.
3. Chronic obstructive airway disease (COAD) including chronic bronchitis and emphysema.
4. Bronchiectasis, pulmonary tuberculosis, pulmonary oedema, interstitial pulmonary fibrosis
5. Tumours of larynx, bronchi, and lungs
6. Drug-induced Cough (e.g., ACE Inhibitors)
7. Diabetes Mellitus, Hypertension
8. Known cases of severe hepatic, renal or cardiac ailments
9. H/o addiction (smoking, alcohol, drugs)
10. Pregnant and lactating women |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in sign and symptoms of Sual-e-Yabis (Dry Cough) |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical assessment for safety assessment |
Investigations will be done at baseline and end of treatment |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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 3 |
|
Date of First Enrollment (India)
|
23/12/2021 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
This study is designed as a multicentric open trial in patients with Sual-e-Yabis (Dry Cough). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at every week. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be two weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy. | S. No. | Ingredients | Botanical Name | Quantity | | 1. | Maghz -e –Behidana | Cydonia oblonga Mill. | 2 g | | 2. | Maghz -e -Tukhm e Kadu | Cucurbita moschata Duchesne. | 2 g | | 3. | Maghz –e- Tukhm- e- Khiyarain | Cucumis sativus Linn. Cucumis melo Linn. | 2 g | | 4. | Zafran | Crocus sativus Linn. | 1 g | | 5. | Samagh -e –Arabi | Acacia arabica wild. | 3 g | | 6. | Nishasta | Starch | 3 g | | 7. | Kateera | Cochlospermum religiosum (Linn.) Alston. | 3 g | | 8. | Maghz- e -Badam shireen | Prunus amygdalus Batsch. | 4 g | | 9. | Rubbus-soos | Glycyrrhiza glabra Linn. | 4 g | | 10. | Maweez Munaqqa | Vitis vinifera Linn. | 4 g | | 11. | Tukhm-e -Khashkhash safaid | Papaver somniferum Linn. | 4 g | | 12. | Nabat safaid | Sugar | 7 g | | 13. | Luab -e –Behidana | Cydonia oblonga Mill. | Q.S. |
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