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CTRI Number  CTRI/2015/02/005525 [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 formulation in the treatment of Palpitation 
Scientific Title of Study   Clinical Validation of Unani Pharmacopoeial Formulation – Dawa-ul-Misk Mutadil Sada in Khafaqan (Palpitation) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
K/P/DMMS CLNVAL/CCRUM 13-14   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  Central Council for Research in Unani Medicine (CCRUM), 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  DEPUTY DIRECTOR 
Affiliation  Central Council for Research in Unani Medicine (CCRUM)  
Address  Central Council for Research in Unani Medicine (CCRUM), 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  Central Council for Research in Unani Medicine (CCRUM), 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@gmail.com  
 
Source of Monetary or Material Support  
Infrastructural support: 1.Central Research Institute of Unani Medicine (CRIUM), Hyderabad 2.Regional Research Institute of Unani Medicine (RRIUM), Aligarh 3.Clinical Research Unit (CRU), Bhurhanpur 4.Regional Research Centre (RRC), Allahabad Monetary Support : Central Council for Research in Unani Medicine (CCRUM), New Delhi  
 
Primary Sponsor  
Name  Central Council for Research in Unani MedicineCCRUM 
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  
Name  Address 
nil  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR MUSHEER AHMAD KHAN  Central Research Institute of Unani Medicine (CRIUM), Hyderabad  AG Colony road, Erragadda,
Hyderabad
ANDHRA PRADESH 		 04023810246

criumhyderabad@gmail.com 
DR SHAIKH NOOR MOHAMMAD   Clinical Research Unit (CRU), Bhurhanpur  Ganpati Naka Burhanpur
West Nimar
MADHYA PRADESH 		 08109462242

mahajankk@rediffmail.com 
Dr Zubair Ahmad Khan  Regional Research Centre (RRC), Allahabad  B- 501/4, G.T.B. Nagar ( Opp. Dulhan Place) Allahabad
Allahabad
UTTAR PRADESH 		 05322551808

rrcallahabad@gmail.com 
DR SHABANA PARVEEN  Regional Research Institute of Unani Medicine (RRIUM), Aligarh  Post Box 70, Near Head Post Office,
Aligarh
UTTAR PRADESH 		 05712704781

rrium_aligarh@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Central Research Institute of Unani Medicine (CRIUM), Hyderabad  Approved 
Clinical Research Unit (CRU), Bhurhanpur  Approved 
Regional Research Centre (RRC), Allahabad  Approved 
Regional Research Institute of Unani Medicine (RRIUM), Aligarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Khafaqan (Palpitation), (1) ICD-10 Condition: R002||Palpitations,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dawa-ul-Misk Motadil Sada  Dawa-ul-Misk Motadil Sada, 5 gm, orally twice daily with water after meals for a period of 4 weeks 
Comparator Agent  nil  na 
 
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
• Patients of Palpitation (heart rate: < 60 or >100 bpm) with and without any of the following symptoms/ signs:
 Ghabrahat
 Feeling of Missed Beat
 Discomfort in Chest
 Sweating
 Dizziness
 
 
ExclusionCriteria 
Details  • History of any heart diseases
• History of hepatic, renal disorders, diabetes mellitus, hypertension, anaemia, COPD
• History of thyroid dysfunction
• History of hypersensitivity to any ingredient of the study drug.
• Participants with history of long term use of any other drugs such as anti-epileptic, anti-arrhythmic and anti-psychotic drugs etc.
• History of 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   4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Hematological and biochemical assessments for safety   4 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)   01/05/2014 
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 Khafaqan (Palpitation)  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 04 weeks. . Laboratory parameters for safety assessment will be conducted at baseline, first follow up and on completion of the protocol therapy.


Composition

Dawa-ul-Misk Mutadil Sada


Name of ingredients  Botanical/Zoological Name   Quantity        


1. Zarishk                    (Berberis vulgaris)                  50 gm             
2. Tabasheer                (Bambusa bambos)                 30 gm             
3. Sandal Safaid          (Santalum album)                    30 gm             


4. Sandal Surkh           (Pterocarpus santalum)           30 gm 


5. Kishneez Khusk Muqashar (Coriandrum sativum) 30 gm 
6. Gul-e-Gaozaban      (Borago officinalis)                 30 gm             


7. Aamla                      (Phylanthus emblica)              30 gm


8. Tukhm-e-Khurfa     (Portulaca oleracea)               30 gm


9. Gul-e-Surkh                        (Rosa damascena)                   20 gm


10. Abresham              (Bombax mori)                        20 gm


11. Darchini                (Cinnamomum zeylanicum)    20 gm


12. Bahaman Safaid    (Centaurea behen)                  20 gm


13. Bahman Surkh      (Savia haematodes)                 20 gm


14. Darunaj Aqrabi     (Doronicum hookrii)               20 gm


15. Ood Hindi             (Aquilaria agallocha)              15 gm


16. Badranjboya          (Melissa parviflora)                 15 gm


17. Mastagi                 (Pistacia lentiscus)                  10 gm


18. Ushna                    (Usnea longissima)                 10 gm


19. Dana Heel Khurd (Elettaria cardamomum)         10 gm


20. Zafran                   (Crocus sativus)                      10 gm


21. Mushk                   (Moschcus moschiferus)          10 gm


22. Ambar Ashhab      (Ambra grasea)                       5 gm


23. Aab-e-Seb Sheerin (Malus domestica)                  450 ml


24. Asl                         (Apis mellifera)                        450 gm


25. Qand Safaid          (Saccharum officinarum)        900 gm



 
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