| 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
|
|
|
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
|
|
|
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. |