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CTRI Number  CTRI/2025/11/097091 [Registered on: 07/11/2025] Trial Registered Prospectively
Last Modified On: 29/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   prospective case series study 
Study Design  Single Arm Study 
Public Title of Study   Effectiveness of homeopathic medicine aletris farinosa in stress incontinence of urine in females of age group 40 to 60 years 
Scientific Title of Study   Effectiveness of aletris farinosa in stress urinary incontinence in females of age group 40 to 60 years: a prospective case series study 
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 Akanksha Kotkar 
Designation  PG Student 
Affiliation  Smt K B Abad Homeopathic medical college 
Address  Smt K B Abad Homeopathic medical college Bhamashah Shree V.D Mehta Dev Vijay P.G. Institute of Homeopathy neminagar Chandwad Homeopathic materia medica department

Nashik
MAHARASHTRA
423101
India 
Phone  8446790105  
Fax    
Email  akankshaskotkar26@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr S N Pareek 
Designation  Associate professor 
Affiliation  Smt K B Abad Homeopathic medical college 
Address  Smt K B Abad Homeopathic medical college Bhamashah Shree V.D Mehta Dev Vijay P.G. Institute of Homeopathy neminagar Chandwad Homeopathic materia medica department

Nashik
MAHARASHTRA
423101
India 
Phone  9271228365  
Fax    
Email  sandeepraj47@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ajay Dahad 
Designation  Principal 
Affiliation  Smt K B Abad Homeopathic medical college 
Address  Smt K B Abad Homeopathic medical college Bhamashah Shree V.D Mehta Dev Vijay P.G. Institute of Homeopathy neminagar Chandwad Homeopathic philosophy department

Nashik
MAHARASHTRA
423101
India 
Phone  9423929797  
Fax    
Email  drdahad@yahoo.com  
 
Source of Monetary or Material Support  
Smt. K.B.Abad Homeopathic Medical College chandwad 423101 Maharashtra India 
 
Primary Sponsor  
Name  Dr. Akanksha Kotkar 
Address  Smt K B Abad Homeopathic medical college chandwad 423101 
Type of Sponsor  Other [self sponsored] 
 
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 Akanksha Kotkar  Smt K B Abad Homeopathic medical college   Smt K B Abad Homeopathic medical college Bhamashah Shree V.D. Mehta Dev vijay P.G. Institute of Homeopathy Neminagar chandwad 423101 Medicine department OPD
Nashik
MAHARASHTRA 
8446790105

akankshaskotkar26@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Smt K B Abad Homeopathic medical college Bhamashah Shree V.D. Mehta Dev vijay P.G. Institute of Homeopathy Neminagar chandwad 423101  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N393||Stress incontinence (female) (male),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  1.Patients with involuntary leakage of urine since last 3 months.

2.Females of age group 40 to 60 years.

3.Patients who provide positive responses to question 1,2 and 3 of QUID scale

4.Patients with signed written informed consent. 
 
ExclusionCriteria 
Details  1.Patients with history of surgery to correct incontinence

2.Pregnant and Lactating females

3.Immunocompromised patients

4.Patients with addiction of alcohol and smoking

5.Patients with modifiable factors such as heavy lifting

6.Women with a history of pelvic organ prolapse Grade 2 or higher or severe pelvic floor disorders requiring surgical correction

7.Women currently participating in another clinical trial for urinary incontinence. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The system for scoring the severity of incontinence.
1.Improved
2.Not improved 
1.Duration of study- 18 months
2.Duration of each case- Each case will be studied for 6 months or till recovery occurs whichever is earlier.
3.Duration of follow up- As per requirement of case or severity of symptoms.
4.clinical outcome assessment will be done at baseline of 3 months and 6 months  
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable   Not applicable 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   10/11/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
INTRODUCTION
The term urinary incontinence is described as any involuntary leakage of urine. The types of urinary incontinence are stress incontinence, urge incontinence, continual incontinence, overflow incontinence.
Stress urinary incontinence
Stress urinary incontinence is termed as sudden, involuntary leakage of urine due to increased intraabdominal pressure. The activities that leads to leakage of urine are coughing, laughing, sneezing, straining or exercising. The risk factors for Stress urinary incontinence include age, obesity, pregnancy, multiple vaginal deliveries.
Grades of Stress Incontinence
Grade I  Incontinence on cough or sneeze
Grade II  With mild exercise
Grade III  with change of posture.

This study aims to investigate the effectiveness of Aletris Farinosa in managing stress urinary incontinence in females aged 40 to 60 years using a case series approach.

Aletris farinosa is indicated in uterine atony, prolapsus of uterus with endometritis, leucorrhoea tendency to abortion. It has been termed as the China of Uterine system.
Aletris Farinosa in Homoeopathic Practice Aletris Farinosa, commonly known as True Unicorn Root or Colic Root is a homoeopathic remedy made from the root of the Aletris plant. It has traditionally been used to treat various female reproductive and urinary system disorders, particularly those related to weakness and dysfunction of the pelvic organs. In homoeopathy, Aletris Farinosa is believed to strengthen the pelvic muscles and tissues, which may be beneficial in conditions like stress urinary incontinence. The remedy is also thought to promote the overall health of the bladder and urinary tract, making it a potentially effective treatment option for Stress Urinary Incontinence.

AIM AND OBJECTIVE
To evaluate the utility of Aletris farinosa in stress urinary incontinence in females of age group 40 to 60 years.
OTHER OBJECTIVES 1
To evaluate the utility of Aletris farinosa in any other associated complaint along with stress urinary incontinence.

1. STUDY DESIGN 
A Prospective case series study.

2. STUDY SETTING 
Cases are collected from
a. OPD and IPD of homoeopathic medical college.
b. Peripheral OPDs run by the homoeopathic medical college.

3. STUDY POPULATION
Females from various socio economic status.
Age between 40 to 60 years will be considered for study.

4. DURATION OF STUDY
18 months during the course after the approval of title.
Follow up
As per the requirement depending upon the severity of symptoms.

5 METHOD OF SELECTION OF STUDY SUBJECT 
a. Inclusion criteria 
1.Patients with involuntary leakage of urine since last 3 months.
2.Females of age group 40 to 60 years.
3.Patients who provide positive responses to question 1,2 and 3 of QUID scale.
4.Patients with signed written informed consent.

b. Exclusion criteria
1.Patients with history of surgery to correct incontinence.
2.Pregnant and Lactating females.
3.Immunocompromised patients.
4.Patients with addiction of alcohol and smoking.
5.Patients with modifiable factors such as heavy lifting.
6.Women with a history of pelvic organ prolapse Grade 2 or higher or severe pelvic floor disorders requiring surgical correction.
7.Women currently participating in another clinical trial for urinary incontinence.

c. Subject withdrawal criteria
1.Cases with irregular follow ups.
2.Patients who are on Parallel treatment for the same or other disease.
3.Patients who are not following protocol.
4.Disease progressing even after receiving treatment for 6 months, will be withdrawn.

6. OPERATIONAL DEFINITION
Stress is Increased intraabdominal pressure which increases the pressure on urinary bladder.
Incontinence is Inability of the body to control evacuative function of urination.
Prospective is future oriented
Aletris farinosa is a Homeopathic medicine.

7. SPECIFICATION OF INSTRUMENTS & RELATED MEASUREMENTS 
 Questionnaire for female urinary incontinence diagnosis 
The system for scoring the severity of incontinence.
Improved Relief of signs and symptoms and general well being of the patient.
Not improved No relief of complaints after sufficient period of treatment.

Sample size 30 cases

Sampling technique Simple random sampling.

Data management and analysis procedure
After filling case record format symptoms of the case will be repertorised using Radar 10 software. Pre and post symptom severity score will be recorded and maintained using excel sheets. The analysis of the collected data will be done as per appropriate statistical test to assess effectiveness of homeopathic intervention.
 
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