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CTRI Number  CTRI/2010/091/000418 [Registered on: 15/09/2010]
Last Modified On:
Post Graduate Thesis   
Type of Trial   
Type of Study    
Study Design  Single Arm Trial 
Public Title of Study   A clinical trial of herbal compound MA-305 in patients with mild to moderate hypertension: A Pilot Study. 
Scientific Title of Study   A clinical trial of herbal compound MA-305 in patients with mild to moderate hypertension: A Pilot Study.  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr.Randeep Guleria, MD, DM, MNAMS 
Designation   
Affiliation   
Address  Professor , Department of Medicine, All India Institute of Medical Sciences, New Delhi ? 110029

New Delhi
DELHI
110029
India 
Phone  011-26593676 (O),011-26198654, (R)  
Fax  91-11-2658866, 26589732   
Email  randeepg@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr.Randeep Guleria, MD, DM, MNAMS 
Designation   
Affiliation   
Address  Professor , Department of Medicine, All India Institute of Medical Sciences, New Delhi ? 110029

New Delhi
DELHI
110029
India 
Phone  011-26593676 (O),011-26198654, (R)  
Fax  91-11-2658866, 26589732   
Email  randeepg@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Mr. S. M. Bhushan,M.pharmacology and M.Pharmaceutics,Dip. bact Director Reseach 
Designation   
Affiliation   
Address  Mr. S. M. Bhushan Director Research, Maharishi Ayurveda Products Pvt. Ltd., A-14, M.C.I.E., Mathura Road, New Delhi ? 110 044

New Delhi
DELHI
110044
India 
Phone  011-26959040,09811158589   
Fax  Phone & TeleFax: 011-26959040  
Email  maharishibhushanrnd@yahoo.co.in   
 
Source of Monetary or Material Support  
Maharishi Ayurveda Products Pvt. Ltd., A-14, M.C.I.E., Mathura Road, New Delhi ? 110 044. Phone & TeleFax: 011-26959040, Mob. 9811158589  
 
Primary Sponsor  
Name  Sh. Anand Shrivastava Chairman & MD, Maharishi Ayurveda Products Pvt. Ltd., A-14, M.C.I.E., Mathura Road, New Delhi ? 110 044. Phone : 011-26959401, 403.  
Address   
Type of Sponsor   
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr.Randeep Guleria, MD, DM, MNAMS, Professor of Medicine  Department of Medicine, All India Institute of Medical Sciences, New Delhi   Department of Medicine, All India Institute of Medical Sciences, New Delhi ,-110029
New Delhi
DELHI 
011-26593676 (O),011-26198654, (R)
91-11-2658866, 26589732
randeepg@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee of All India Institute of Medical Sciences.   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Mild to Moderate Hypertension. ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cardimap (MA 305  A herbal formulation developed by Maharishi Ayurveda to arrest, abate and control hypertension. It is presented in the form of tablet and contains the following herbal ingredients. 1 Rauwolfia serpentina ? (Sarpagndha) 2 Nardostachys jatamansi ? (Jatamansi) 3 Bacopa monnieri ? (Brahmi) 4 Convolvulus pluricaulis - (Shankpushpi) 5 Piper longum ? (Pippali) Two Tablets of 500mg each twice a day with water.  
Comparator Agent  No Comparator agent to be used  None 
 
Inclusion Criteria  
Age From   
Age To   
Gender   
Details  1.. Patients who are willing to participate in the study. `2 . Aged 18 to 70 yrs. `3. Primary hypertensive patients. `4. Patients with pre hypert ensive ( SBP: 120-130, DBP: 80-89) and stage 1( SBP:140-159, DBP: 90-99) (According to JNC 7 criteria). ``5. patients with stable blood pressure and with no significant change in their therapy over the last 4 ``weeks prior to entry into the study.  
 
ExclusionCriteria 
Details  (a) Patients unwilling to participate. (b) Pregnancy and breast-feeding. (c) Concomitant severe diseases. (d) Uncontrolled hypertension.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The aim of study is to evaluate the efficacy and tolerability of herbal compound MA ?305 in patients with mild to moderate hypertension.   
 
Secondary Outcome  
Outcome  TimePoints 
NO   
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="" 
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/ Phase 4 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/09/2010 
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)   Open to Recruitment 
Recruitment Status of Trial (India)   
Publication Details    
Brief Summary   The aim of the study is to evaluate the safety efficacy & tolerability of herbal compound Cardimap (MA-305) in patients with mild to moderate hypertension. Patients with mild to moderate hypertension who meet the study criteria will be included after taking a written informed consent. During the initial 2- weeks baseline period and at the end of 12- weeks of active therapy, all basic investigations including haemogram, biochemistry will be done. Patient will be clinically reviewed after every 4 weeks. Blood pressure will be monitored in supine, sitting and standing position. In baseline period when blood pressure becomes stable, patients will be given the study medicine along with antihypertensive drugs, which have been prescribed earlier. All antihypertensive drugs will be continued and the patient will be regularly monitered during the study period. The trial medicine will be stopped after 12- weeks. Patients will be followed up for another 2-weeks without medicine. Side effects if any will be recorded in the case record form. After completion of the study, we will evaluate the result with appropriate statistical analysis.  
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