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CTRI Number  CTRI/2025/11/097784 [Registered on: 20/11/2025] Trial Registered Prospectively
Last Modified On: 19/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani
Other (Specify) [Therapeutic]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Research on Uterine Prolapse in Unani Medicine 
Scientific Title of Study   Efficacy of Abzan of Habbul Aas, Izkhar and Post Anar with Pelvic Floor Muscle Exercises in Nutu al Rahim Uterovaginal Prolapse : A Randomized Standard Controlled 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 SONAM A 
Designation  PG SCHOLAR 
Affiliation  Government Unani Medical College and Hospital 
Address  Room no G11, Department of Ilmul Qabalat wa amraze niswan Government Unani Medical College and Hospital Basaweshwaranagar Bangalore

Bangalore
KARNATAKA
560079
India 
Phone  6361291647  
Fax    
Email  sonamkhan8020@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aisha Anjum A 
Designation  Professor and HOD 
Affiliation  Government Unani Medical College and Hospital 
Address  Room no G11, Department of Ilmul Qabalat wa amraze niswan Government Unani Medical College and Hospital Basaweshwaranagar Bangalore

Bangalore
KARNATAKA
560079
India 
Phone  8951592300  
Fax    
Email  dr.aanjuma@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aisha Anjum A 
Designation  Professor and HOD 
Affiliation  Government Unani Medical College and Hospital 
Address  Room no G11, Department of Ilmul Qabalat wa amraze niswan Government Unani Medical College and Hospital Basaweshwaranagar Bangalore


KARNATAKA
560079
India 
Phone  8951592300  
Fax    
Email  dr.aanjuma@gmail.com  
 
Source of Monetary or Material Support  
Government Unani Medical College and Hospital Bangalore 560079 
 
Primary Sponsor  
Name  Government Unani Medical College and Hospital Bangalore 560079 
Address  Room no G11, Department of Ilmul Qabalat wa amraze niswan, Government Unani Medical College and Hospital Basaweshwaranagar 
Type of Sponsor  Government medical college 
 
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 SONAM A  Government Unani Medical College and Hospital  Room no G11, Department of Ilmul Qabalat wa amraze niswan,Government Unani Medical College and Hospital Basaweshwaranagar
Bangalore
KARNATAKA 
6361291647

sonamkhan8020@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee (IEC) for Biomedical Research Government Unani Medical College Bengaluru  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N812||Incomplete uterovaginal prolapse,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Local Administration (Abzan) with Pelvic Floor Muscle Exercises  Habbul Aas, Izkhar, and Post Anar each 8g will be coarsely powdered and Joshanda will be prepared in 1 litre of water with 24g of the above-mentioned drugs till it is reduced to 500 ml, then mixed with 4 litres of sterilized warm water and will be given locally as Abzan (sitz bath) every day for 28 sittings except during menses. 
Comparator Agent  Pelvic Floor Muscle Exercises with Placebo for 28 sittings  Participants will be advised to take 1 tablet(500mg)of Placebo(wheat flour) once daily along with Pelvic Floor Muscle Exercises for 28 days 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  1.Married participants between the age group of 25 to 65 years.
2.Participants with symptoms like vaginal protrusion, feeling of bulge, urinary incontinence, white discharge, low back ache, dyspareunia, frequency and urgency of urine, constipation.
3.Participants with 1st and 2nd degree uterovaginal prolapse as per Baden Walker Halfway Scoring System with or without symptoms. 
 
ExclusionCriteria 
Details  1.Participants with 3rd and 4th-degree uterovaginal prolapse.
2.Participants with any malignancies, uncontrolled diabetes more than 200 mg per dL and hypertension more than 140 by 90 mm of Hg.
3.Participants with spinal deformities, inter vertebral disc prolapse, and lumbar spondylosis 
 
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 
Baden Walker Halfway System
 
Before and After
 
 
Secondary Outcome  
Outcome  TimePoints 
1.VAS Scale for symptoms associated with UVP
2.PFI Q 7 scale score 
1.VAS Scale for symptoms associated with UVP Base line,7th day,14th day,21st day,28th day
2.PFI Q 7 scale score before and after  
 
Target Sample Size   Total Sample Size="43"
Sample Size from India="43" 
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)   30/11/2025 
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 Yet Recruiting 
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  
Nutu al Rahim uterovaginal prolapse is a protrusion of the vaginal walls and or uterus. resulting from the descent of the pelvic organs. It is a common gynecological condition seen in elderly women. Pelvic Organ Prolapse POP is a pelvic floor disorder that affects the quality of life in millions of women in the US and around the world. World Health Organization estimates the Global prevalence of uterovaginal prolapse as 2 to 20 percent among women younger than 45 years of age. The prevalence of symptomatic POP, which includes uterine prolapse, was 33 percent in pre menopausal women and 10percent in post menopausal women. In India, Utero Vaginal Prolapse UVP is the most frequent cause of gynecological morbidity. Women with UVP typically report symptoms such as sensation of vaginal protrusion, a feeling of a bulge, and heaviness in the lower abdomen. In addition to these sensations, some women may experience urinary issues like urinary incontinence, voiding dysfunction, bowel problems like constipation or fecal incontinence or sexual dysfunction dyspareunia.

The treatment of choice in modern medicine is preventive, pessary and surgery. Though surgery is effective for significant prolapse, it increases the economic burden and has 5 percent post operative complications and a 12 percent recurrence rate respectively. Hence there is a need for alternative treatment that is safe, effective, easily available, free from side effects, and non surgical.

In Classical Unani Literature, Nutu al Rahim is mentioned as, a condition in which the uterus descends into the vagina or outside the introitus from its normal place. It is predominantly caused by the accumulation of Balgham Lazij in Ribatat al Rahim which causes its weakness leading to Nutu al Rahim. It usually occurs in older women having excessive Rutubat in their bodies. The Unani system of medicine uses various drugs and regiminal therapies for uterovaginal prolapse. Abzan is one such procedure where the patient sits in a tub filled with plain or medicated water such as Joshanda or khaisanda up to the level of the umbilicus. Unani physicians frequently recommend it for gynecological disorders like genital prolapse, vaginal infections, pelvic inflammatory disease, menstrual disorder, healing of episiotomy wounds, and hemorrhoids.

In Unani medicine, many single, compound drugs, and regiminal therapies are mentioned in the management of Nutu al Rahim, of these Abzan of Habbul Aas, Izkhar, and Post Anar has been selected for the treatment in the present study. These drugs have properties of Habis hemostatic, Qabiz astringent,  Muqawwi i Rahim uterine tonic, Mujaffif desiccant, and Musakkin Alam analgesic properties, they can help in the stimulation of instinct heat and strengthening the body. They have pharmacological properties like antioxidant, anti-inflammatory, antimicrobial, antifungal, antibacterial, antiviral, and diuretic Therefore, the present study has been taken up to determine the effect of this Unani formulation along with pelvic floor muscle exercises in 1st and 2nd degree uterovaginal prolapse.
 
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