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CTRI Number  CTRI/2025/09/094342 [Registered on: 08/09/2025] Trial Registered Prospectively
Last Modified On: 06/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   How well Solidago virgaurea mother tincture works as an add on treatment in reducing the remaining urine in the bladder after urination in patients with urinary retention problems: An open study with randomly assigned groups. 
Scientific Title of Study   EFFECTIVENESS OF SOLIDAGO VIRGAUREA Q AS AN ADD-ON THERAPY IN REDUCING POST-VOID RESIDUAL URINE IN PATIENTS WITH URINARY RETENTION DISORDERS: AN OPEN-LABEL RANDOMISED CONTROLLED TRIAL 
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 RAGHUKUL AMAR DUBEY 
Designation  POST GRADUATE RESIDENT 
Affiliation  Dr MPK HOMOEOPATHIC MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE 
Address  UNIT 1 ROOM NO 1 DEPARTMENT OF PRACTICE OF MEDICINE 10, 11 AND 12 WARD NO 36, SAIPURA, SANGANER, JAIPUR, RAJASTHAN 302029

Jaipur
RAJASTHAN
302029
India 
Phone  7669891008  
Fax    
Email  amardubey409@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr CHANDRA SHEKHAR SHARMA 
Designation  PROFESSOR 
Affiliation  Dr MPK HOMOEOPATHIC MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE 
Address  UNIT 1 ROOM NO 1 DEPARTMENT OF PRACTICE OF MEDICINE 10, 11 AND 12 WARD NO 36, SAIPURA, SANGANER, JAIPUR, RAJASTHAN 302029

Jaipur
RAJASTHAN
302029
India 
Phone  9314539277  
Fax    
Email  drcssharma.jaipur@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr RAGHUKUL AMAR DUBEY 
Designation  POST GRADUATE RESIDENT 
Affiliation  Dr MPK HOMOEOPATHIC MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE 
Address  UNIT 1 ROOM NO 1 DEPARTMENT OF PRACTICE OF MEDICINE 10, 11 AND 12 WARD NO 36, SAIPURA, SANGANER, JAIPUR, RAJASTHAN 302029

Jaipur
RAJASTHAN
302029
India 
Phone  7669891008  
Fax    
Email  amardubey409@gmail.com  
 
Source of Monetary or Material Support  
Dr GIRENDRA PAL HOMOEOPATHIC HOSPITAL AND RESEARCH CENTRE COLLEGIATE HOSPITAL of Dr MPK HOMOEOPATHIC MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE A CONSTITUENT COLLEGE OF HOMOEOPATHY UNIVERSITY, SAIPURA, SANGANER, JAIPUR, RAJASTHAN 302029 
Dr MADAN PRATAP KHUTETA HOMOEOPATHIC HOSPITAL, VANASTHALI MARG, SINDHI CAMP, JAIPUR, RAJASTHAN 302001 
 
Primary Sponsor  
Name  Dr MPK HOMOEOPATHIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE 
Address  UNIT 1 ROOM NO 1 DEPARTMENT OF PRACTICE OF MEDICINE 10, 11 AND 12 WARD NO 36, SAIPURA, SANGANER, JAIPUR, RAJASTHAN 302029 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr RAGHUKUL AMAR DUBEY  Dr GIRENDRA PAL HOMOEOPATHIC HOSPITAL AND RESEARCH CENTRE  UNIT 1 ROOM NO 1 DEPARTMENT OF PRACTICE OF MEDICINE 10, 11 AND 12 WARD NO 36, SAIPURA, SANGANER, JAIPUR, RAJASTHAN 302029
Jaipur
RAJASTHAN 
7669891008

amardubey409@gmail.com 
Dr RAGHUKUL AMAR DUBEY  Dr MADAN PRATAP KHUTETA HOMOEOPATHIC HOSPITAL  ROOM NO 6 VANASTHALI MARG, SINDHI CAMP, JAIPUR, RAJASTHAN 302001
Jaipur
RAJASTHAN 
7669891008

amardubey409@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE HOMOEOPATHY UNIVERSITY JAIPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N33||Bladder disorders in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  INDIVIDUALIZED HOMOEOPATHIC MEDICINE  The dose and repetition of medicines may vary according to the susceptibility and sensitivity of the patient, the acute or chronic nature of the disease and the age and vitality of the individual. In this trial, dosage, repetition and dispensing (in the form of globules no. 40) will be as per the need of the case and the guidelines of the organon of medicine. Reassessment will be done at the end of 3 months.  
Intervention  INDIVIDUALIZED HOMOEOPATHIC MEDICINE PLUS SOLIDAGO VIRGAUREA MOTHER TINCTURE  The dose and repetition of medicines, including mother tinctures, may vary according to the susceptibility and sensitivity of the patient, the acute or chronic nature of the disease and the age and vitality of the individual. In this trial, dosage, repetition and dispensing (in the form of globules no. 40) of individualised homoeopathic medicine will be as per the need of the case and the guidelines of the organon of medicine. The selected dose of mother tinctures (approx. 20 to 60 drops) represents a minimum, safe and standardized range.the dose and repetition will be determined according to the need of the case and previous research evidences. Reassessment will be done at the end of 3 months, with all interventions closely monitored for safety throughout the study. 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Patients giving consent.
2.Patients maintaining proper follow-up.
3.Diagnosed cases of elevated post-void residual urine (i.e,more than 10 percent of pre void urine) confirmed by ultrasound/bladder scan or catheterisation.
4.Patients willing to undergo individualized homoeopathic treatment and comply with the trial protocol.
5.Patients presenting with symptoms of urinary retention disorders such as incomplete voiding, frequent urging, burning micturition or sensation of fullness, urine incontinence etc.
6.Patients currently on alpha-blockers, anticholinergics, or other modern medications, phytotherapy or herbal urinary medication specifically targeting urinary retention disorders, still not getting relief.  
 
ExclusionCriteria 
Details  1.Patients who do not provide consent.
2.Patient fails to maintain proper follow-up.
3.Patients with complete retention of urine for more than 24 hours.
4.Patients are on dialysis.
5.Patient with vesicoureteral reflex.
6.Pregnant or lactating women.
7.Known hypersensitivity or intolerance to Solidago virgaurea or any other constituents of the preparation.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
PARTICIPANTS RECEIVING SOLIDAGO VIRGAUREA MOTHER TINCTURE ALONG WITH INDIVIDUALIZED HOMOEOPATHIC MEDICINES ARE EXPECTED TO SHOW A GREATER REDUCTION IN THE POST VOID RESIDUAL URINE COMPARED TO THOSE RECEIVING INDIVIDUALIZED HOMOEOPATHIC TREATMENT ALONE  PRE AND POST VOID OF URINE WILL BE ASSESSED BASED ON ALTERATIONS IN ULTRASOUND BLADDER SCAN OR CATHETERISATION AT THE END OF 3 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
AT THE END OF THE STUDY WE EXPECT THAT SOLIDAGO VIRGAUREA MOTHER TINCTURE NOT ONLY MANAGED THE POST VOID RESIDUAL URINE BUT ALSO ITS COMORBIDITIES(USING DAILY BLADDER DIARY)  12 MONTHS 
MOTHER TINCTURE DOSES ARE EMPIRICALLY DERIVED AND NOT YET RIGOROUSLY VALIDATED; THEREFORE, THIS STUDY WILL CONTRIBUTE TOWARD DOSE VALIDATION. THE TRIAL IS EXPECTED TO GENERATE DATA TO SUPPORT FUTURE DOSE–RESPONSE EVALUATIONS AND FACILITATE EVIDENCE-BASED REFINEMENT OF MOTHER TINCTURE USE IN HOMOEOPATHY AS AN ADD-ON THERAPY.  12 MONTHS 
 
Target Sample Size   Total Sample Size="126"
Sample Size from India="126" 
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 
Date of First Enrollment (India)   21/09/2025 
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="0"
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   AIM
 To evaluate the Effectiveness of Solidago virgaureaQ as an add-on therapy when given along with an individualised homoeopathic medicine in reducing the post-void residual urine in patient with urinary retention disorders.

OBJECTIVES
1. To assess the change in post-void residual urine volume before and after treatment in both intervention and control groups.
2. To evaluate the improvement in urinary retention symptoms before and after treatment in both intervention and control groups using a standardized system (e.g daily bladder diary- as per homoeopathic case taking performa and including symptoms of urinary retention disorders).
3. To compare the safety and tolerability profile of the add-on use of Solidago virgaureaQ with standard therapy alone. 
4. To evaluate whether solidago virgaurea Q in both intervention and control groups has more effectiveness on obstructive or non obstructive urinary retention disorder.

JUSTIFICATION OF STUDY
Post-void residual urine (PVRU) is a frequently overlooked but clinically important issue in both men and women, particularly in the elderly and those with lower urinary tract dysfunction. Persistent elevated PVRU can significantly impair quality of life and may lead to complications such as urinary tract infections, chronic urinary retention, overflow incontinence, and upper urinary tract damage. Current standard treatments—including alpha blockers, 5-alpha reductase inhibitors, or intermittent catheterization—are only partially effective for many patients and are often accompanied by adverse effects such as hypotension, dizziness, and reduced sexual function. These limitations highlight the urgent need for safer, more effective adjunct therapies to enhance bladder emptying and reduce complications associated with high residual urine. 
Solidago virgaureaQ (mother tincture), a homoeopathic preparation derived from the European goldenrod plant, has been used in traditional and homoeopathic medicine for its diuretic, anti-inflammatory, and bladder-toning properties. It is commonly prescribed for urinary tract conditions such as cystitis, nephritis, and bladder irritation. However, despite its frequent use in integrative medicine, there is a lack of robust clinical evidence—particularly from randomized controlled trials—to support its role as an effective therapeutic agent for elevated PVRU.
The proposed study is significant for several reasons:
1. Fills a Research Gap: To date, no randomized controlled trials have rigorously evaluated the Effectiveness of Solidago virgaurea Q in patients with elevated post-void residual urine. This study seeks to provide high-quality clinical evidence in this underexplored area. 
2. Supports Integrative Health Approaches: With increasing patient demand for complementary and alternative therapies that are safe and effective, this research could support the integration of homoeopathy into conventional urology practice, thereby offering a holistic management strategy.
3. Enhances Patient Outcomes: If found effective, the use of Solidago virgaureaQ as an adjunct could reduce PVRU levels more efficiently, improve bladder function, and decrease dependence on invasive interventions like catheterization, thereby improving patient satisfaction and quality of life. 
4. Minimizes Adverse Effects: Given its favorable safety profile, Solidago virgaureaQ could provide a well-tolerated, non-invasive alternative or complement to existing pharmacological treatments. 
5. Cost-Effective and Accessible: Homoeopathic mother tinctures are generally affordable and widely available, making this intervention particularly suitable for use in low-resource settings or in community health programs where access to specialized urological care is limited. 
 
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