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CTRI Number  CTRI/2020/02/023124 [Registered on: 05/02/2020] Trial Registered Prospectively
Last Modified On: 15/03/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Effectiveness of Homoeopathic Treatment in Urinary Tract Infections  
Scientific Title of Study   Open labeled Non-randomized Clinical Case Series Pilot study in the Management of Urinary Tract Infections treated with Specific Homoeopathic Medicines 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr H Venkatesan 
Designation  Research Coordinator & Associate Professor 
Affiliation  Vinayaka Missions Homoeopathic Medical College and Hospital 
Address  Room No 5, Dept of Research & Development, First Floor, PG Block, Vinayaka Missions Homoeopathic Medical College and Hospital, NH 47, Sankari Main Road, Seeragapadi PO

Salem
TAMIL NADU
636308
India 
Phone  9865134561  
Fax    
Email  venkathompath@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr H Venkatesan 
Designation  Research Coordinator & Associate Professor 
Affiliation  Vinayaka Missions Homoeopathic Medical College and Hospital 
Address  Room No 5, Dept of Research & Development, First Floor, PG Block, Vinayaka Missions Homoeopathic Medical College and Hospital, NH 47, Sankari Main Road, Seeragapadi PO

Salem
TAMIL NADU
636308
India 
Phone  9865134561  
Fax    
Email  venkathompath@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr H Venkatesan 
Designation  Research Coordinator & Associate Professor 
Affiliation  Vinayaka Missions Homoeopathic Medical College and Hospital 
Address  Room No 5, Dept of Research & Development, First Floor, PG Block, Vinayaka Missions Homoeopathic Medical College and Hospital, NH 47, Sankari Main Road, Seeragapadi PO

Salem
TAMIL NADU
636308
India 
Phone  9865134561  
Fax    
Email  venkathompath@gmail.com  
 
Source of Monetary or Material Support  
Vinayaka Missions Homoeopathic Medical College and Hospital, NH 47, Sankari Main Road, Seeragapadi PO, Salem, Tamilnadu, Pincode 636308 
 
Primary Sponsor  
Name  Vinayaka Missions Homoeopathic Medical College and Hospital 
Address  NH 47, Sankari Main Road, Seeragapadi PO, Salem, Tamilnadu, Pincode 636308 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  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 H Venkatesan  Vinayaka Missions Homoeopathic Medical College and Hospital  Room No : 5 B - Dept of Practice of Medicine, Vinayaka Missions Homoeopathic Medical College and Hospital,NH 47, Sankari Main Road, Seeragapadi PO, Salem, Tamilnadu, Pincode 636308
Salem
TAMIL NADU 
9865134561

venkathompath@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N390||Urinary tract infection, site notspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
Intervention  Specific Homoeopathic Medicines: Apis mellifica, Berberis Vulgaris, Cantharis, Pareira brava, Sarsaparilla, Staphysagria and Terebinthina.   Suitable Homoeopathic Medicines from the said list will be selected according to the Homoeopathic Principles of Symptom Similarity & Guiding symptoms and will be Prescribed to the patient. The medicines will be Prescribed in 30 Centesimal Potency. 5 Medicated globules of 30 size will be prescribed orally to the patients in Morning and Night before food. Treatment will be given for 15 Days to 30 Days according to the Health Status of the Patients .  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Patients with Signs and Symptoms of Urinary Tract Infection.
2. Patients with elevated Pus cells & Epithelial Cells in Urine Routine.

 
 
ExclusionCriteria 
Details  Patients with signs of Systemic Infection.
Patients with signs of Pyelonephritis & Glomerulonephritis.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Symptomatic Relief of the Urinary Complaints.
Reduction in the Pus Cells and Epithelial Cells in the urine Routine.  
30 Days 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  NA 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/02/2020 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
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)?  

Response - NO
Brief Summary
Modification(s)  

A urinary tract infection, or UTI, is an infection of the urinary tract. The infection can occur at different points in the urinary tract, including:

Bladder -- An infection in the bladder is also called cystitis or a bladder infection.

Kidneys -- An infection of one or both kidneys is called pyelonephritis or a kidney infection.

Ureters -- The tubes that take urine from each kidney to the bladder are rarely the only site of infection.

Urethra -- An infection of the tube that empties urine from the bladder to the outside is called urethritis.

Most UTIs are caused by bacteria that enter the urethra and then the bladder. The infection most commonly develops in the bladder, but can spread to the kidneys. Most of the time, your body can get rid of these bacteria. However, certain conditions increase the risk of having UTIs.

Women tend to get them more often because their urethra is shorter and closer to the anus than in men. Because of this, women are more likely to get an infection after sexual activity or when using a diaphragm for birth control. Menopause also increases the risk of a UTI.

The symptoms of a bladder infection include:

Cloudy or bloody urine, which may have a foul or strong odor

Low grade fever in some people

Pain or burning with urination

Pressure or cramping in the lower abdomen or back

Strong need to urinate often, even right after the bladder has been emptied

Complications may include:

Life-threatening blood infection (sepsis) -- The risk is greater among the young, very old adults, and people whose bodies cannot fight infections (for example, due to HIV or cancer chemotherapy).

Kidney damage or scarring.

Kidney infection.

By Literature Review it is evident that Homoeopathic medicines are highly effective in the management of such cases and with the flexibility in potencies the Patients gets the best suited medicine which treats him internally securing from the recurrence of the same condition again. 

This study is aimed as the Pilot Study to find the Clinical Evidence for a Future Complete Trial.
 
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