| 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
|
|
|
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
|
|
|
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. |