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
|
|
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
|
|
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. |