| CTRI Number |
CTRI/2024/02/062992 [Registered on: 21/02/2024] Trial Registered Prospectively |
| Last Modified On: |
26/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathy for Acute Cystitis in Female. |
|
Scientific Title of Study
|
A Randomised Placebo Control Clinical Trial To Verify The Efficacy Of Homoeopathic Medicines In Cases Of Acute Cystitis In Female. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Janakiben Rajnikant Bhanvadia |
| Designation |
PhD Scholar |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
Department of Forensic Medicine & Toxicology, Rajkot Homoeopathic Medical College, Behind Jainath complex, Makkam Chowk, Gondal Road, Rajkot.
Rajkot
GUJARAT
360002
India |
| Phone |
9408743904 |
| Fax |
|
| Email |
bhanvadiajanki@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kirtida Desai |
| Designation |
Professor & HOD, Dept. of Practice Of Medicine |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College |
| Address |
Department of Practice Of Medicine, P.G. Division,Jawaharlal Nehru Homoeopathic Medical College,
Parul University, P.O. Limda, Tal. Waghodia, Dist. Vadodara,Gujarat-391760 India
Vadodara
GUJARAT
391760
India |
| Phone |
9574424363 |
| Fax |
|
| Email |
kirtida.desai@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Janakiben Rajnikant Bhanvadia |
| Designation |
PhD Scholar |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
Department of Forensic Medicine & Toxicology, Rajkot Homoeopathic Medical College, Behind Jainath complex, Makkam Chowk, Gondal Road, Rajkot.
Rajkot
GUJARAT
360002
India |
| Phone |
9408743904 |
| Fax |
|
| Email |
bhanvadiajanki@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sainath Homoeopathic Hospital, attached with Rajkot Homoeopathic Medical College,Rajkot, Gujarat |
|
|
Primary Sponsor
|
| Name |
Rajkot Homoeopathic Medical College |
| Address |
Rajkot Homoeopathic Medical College, Behind Jainath Complex, Makkam Chowk, Gondal Road, Rajkot |
| 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 Janakiben Rajnikant Bhanvadia |
Sainath Homoeopathic Hospital |
Room no. 103, Department of Obstetrics and Gynaecology, Rajkot Homoeopathic Medical College, Behind Jainath Complex, Makkam Chowk, Gondal Road, Rajkot
Rajkot
GUJARAT |
9408743904
bhanvadiajanki@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Human research-Rajkot Homeopathic Medical College(RHMC),Parul University, Gujarat |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N300||Acute cystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised Homoeopathic Medicine |
Individualised Homoeopathic Medicine, which could be and medicine and is derived from the Homoeopathic source and prepared according to the Homoeopathic Pharmacopoeia. the selection of the intervention medicine would be done according to totality of symptoms. Patients condition of disease would also be noted. Duration of treatment- 6 months. Modes of Administration- Oral (sublingual).Selection of Potency, dose and Repetition:Individualised Homoeopathic Medicine As per the need of case. |
| Comparator Agent |
Placebo, indistinguishable in appearance from verum |
Each dose of placebo shall consist of 4 globules (no.30) of cane sugar, to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the case. All the other instructions will be same as intervention arm except this arm will receive placebo. Each dose of placebo will be prepared with non-medicated globules. The patient will be advised to maintain adequate sleep, proper diet, practice yoga, meditation or exercise daily. Duration of therapy: 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. Pre-diagnosed cases of Acute cystitis or new cases showing sign and symptoms of acute cystitis.
2. Female patients
3. Female of age group 18 years to 60 years. |
|
| ExclusionCriteria |
| Details |
1. Age less than 18 years and more than 60 years.
2. Patients with acute cystitis who were on other therapeutic measures.
3. Patients with other systemic disorders and other urinary tract diseases.
4. Substance induced acute cystitis.
5. Pregnancy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To ascertain the role of Homoeopathic Medicines in cases of Acute Cystitis in female by using Acute Cystitis Symptom Score (ACSS) |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To prepare therapeutic compendium of Homoeopathic Medicines in cases of Acute Cystitis in Female. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
26/02/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The term acute simple cystitis to refer to an acute urinary tract infection (UTI) that is presumed to be confined to the bladder. Such infections lack signs or symptoms that suggest an infection extending beyond the bladder, which include:
Fever (>99.9°F/37.7°C). Other signs or symptoms of systemic illness (including chills or rigors, significant fatigue or malaise beyond baseline). Flank pain. Cystitis among women is extremely common. The shorter distance from the anus to the urethra likely explains why women are at higher risk for urinary tract infections (UTIs) than men. Among otherwise healthy women, risk factors for cystitis include recent sexual intercourse and a history of UTI. Use of spermicide-coated condoms, diaphragms, and spermicides alone are also associated with an increased cystitis risk. Other comorbidities, such as diabetes mellitus and structural or functional urinary tract abnormalities, can also increase the risk of cystitis. A study consisting of 2 044 065 females who were 15-50 years of age during the study period (1997-2018) .The study identified 546 076 first events of uncomplicated cystitis (26.7% of the study population), In fully adjusted models, rural living was associated with lower risks of uncomplicated cystitis compared to urban living, while both Middle Eastern/North African and Latin American/Caribbean women had higher risks compared to Swedish women. Low education and low income were also associated with higher risks compared to high education and high income. in this trial the investigator intend to assess the efficacy of individualised Homoeopathic Medicine for Acute Cystitis in Female on 100 patients in a single blind, randomised, parallel arm, placebo controlled design in the outpatient of Sainath Homoeopathic Hoapital, attached with Rajkot Homoeopathic Medical College, Dist-Rajkot 360002, Gujarat, India. The patients will be prescribed either individualised Homoeopathic Medicine or identical Placebo. Data will be gathered at base line and after completing treatment using acute Cystitis Symptoms Score. Randomization will be computer generated. The collected data will be subjected to statistical analysis. The main aim is to evaluate the effectiveness of individualised Homoeopathic Medicine than placebo in cases of Acute Cystitis in Female. |