Unani treatment regimens in uterovaginal prolapse
- Conditions
- Uterovaginal prolapse, unspecified,
- Registration Number
- CTRI/2022/02/040110
- Lead Sponsor
- National institute of unani medicine
- Brief Summary
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|**Brief resume of the intended work:**
**Need of the study**:
Uterovaginal prolapse (UVP) is a global health crisis in the aging female and is one of the commonest reproductive morbidity in developing countries.1 It is the herniation of the uterus into or beyond the vagina as a result of failure of the ligamentous and fascial supports. It often coexists with prolapse of the vaginal walls, involving the bladder or rectum.2 The incidence of uterine prolapse in North India is 7.6%, in east India 20%, in southern India i.e. Karnataka is 3.4%.3 Pelvic organ prolapses (POP) when defined by symptoms has a prevalence of 3-6% and up to 50% when based upon vaginal examination. The global prevalence of uterine prolapse is 2%–20%. It causes physical and psychosocial problems affecting the quality of life of patients.4
According to unani in this disease the uterus protrudes partially or completely outside the introitus.5 According to unani concept it is predominantly caused by the accumulation of *balghame lazij* in *ribÄá¹Ät-i-**rahim* which causes its weakness leading to *InzilÄq al-rahim*. Although in conventional system of medicine prolapse is treated conservatively with medications, pessaries, physiotherapy or behavioral therapy, surgical interventions are required in advanced cases of prolapse.1 Studies show that application of surgery in elderly population requiring it are not without risk of complication and recurrence, thereby decreasing the willingness of the patients.6,7 Surgery aims at only relieving the symptoms and does not cures the problem completely. Studies have found that there are 50% chances of recurrence of prolapse following surgery and also the best surgical approach to achieve anatomical cure, resolution of symptoms, and low rates of recurrence is not known 2,8,9. Finally, the costs for prolapse related surgery are high and are expected to substantially increase owing to the ageing population and the higher prevalence of prolapse in older women .10 This allows herbal or traditional medicine greatly desirable, cost effective and risk free as a treatment option.
Many plant origin drugs as *Aqaqia, Murmakki, Kundur, Ladan, Gulnar, Barg-e-aas, Gul-e- surkh, Adas muqasshar, Mazoo sabz etc* 5are used in the form of *firzaja* However, this unani formulation consisting of *Gul*-i-*surkh*, *Izkhar*, *Aas* and *Aqaqiyya* 11 has properties of *qabiz, habis, muhalill e auram, mujaffif, musakkin, dafe alam etc.*12 Also*, these drugs have antioxidant, antispasmodic, anti-inflammatory, analgesic, antibacterial.*13 Therefore, the present study has been undertaken to evaluate the effect of this unani formulation as well as dry cupping in 1st and 2nd degree uterovaginal prolapse.
**Review of literature:**
In unani literature uterine prolapse is known as *InqilÄb al- rahim/ NutÅ« al- rahim/ KhurÅ«j al- rahim/ BarÅ«z al- rahim/ InzilÄq al-rahim*. Unani physician have stated that *InqilÄb al- rahim* (prolapse) occurs due to 3 causes: *AsbÄb-i-khÄrij’* (external cause) which includes heavy weight lifting/shouting/fall from height, *AsbÄb-i-wilÄd* (obstetric cause) which includes obstructed labor/big baby, *AsbÄb-i-dÄkhil’* (internal cause) includes *excessive ratÅ«bat.*5 Several risk factors for prolapse include pregnancy, childbirth, connective tissue abnormality, aging, menopause, pelvic floor muscle weakness, obesity & chronically raised intra-abdominal pressure.14 Symptoms include severe pain in back, anus and pelvis, something coming down in vagina, obstruction in micturition & defecation, leucorrhea if the cause is excessive *balghami ratÅ«bat* .5,15
The **Baden–Walker Halfway Scoring System** is the next system used, especially in clinical circumstances. The assignment of a score to each of six specific midline sites encodes a large amount of information in a small amount of time and space.16The symptoms of prolapse include a lump or protrusion bulging down to vagina, pelvic heaviness, and backache. In addition, most of the patient suffer sexual dysfunction such as dyspareunia & vaginal dryness, urinary symptoms (Incontinence, urgency, frequency, incomplete evacuation of urine), bowel symptoms (Straining during defecation, incomplete evacuation of stool, incontinence of flatus or stool).14
The FPFQ or Australian questionnaire is a complete questionnaire that can assess all the domains, besides addressing the perception of symptoms, impact on QoL and degree of bother, consisting of 42 questions distributed in four domains: bladder function, bowel function, POP symptom and sexual function.17 The Evidences suggests that women with symptomatic mild prolapse might benefit from pelvic floor muscle training (KEGELS EXERCISE).10
The management of prolapse in conventional medicine include conservative management (pelvic floor muscle training or pessary treatment) and surgical correction.10 *Aabzan* (sitz bath) of the unani formulation consisting of *Gul e surkh, Izkhar and Hab-ul-aas* followed by *Hamūl* of *Aqaqia* 11along with dry cupping is useful for treating prolapse as mentioned in unani text.Cupping is thought to act mainly by increasing local blood circulation and relieving the painful muscle tension. It mainly involves improving microcirculation, promoting capillary endothelial cell repair, accelerating granulation, and angiogenesis in the regional tissues.18,19
**Objectives of study:**
To evaluate the effect of *Aabzan & Hamūl* of Unani medicine along with dry cupping in first and second degree uterovaginal prolapse (*Nutū al- Rahim).*
**MATERIAL METHODS**
**Source of data**: Patients attending the female OPD and IPD, Department of Ilmul Qabalat wa Amraze Niswan, NIUM, Bengaluru
**Study design:** An Interventional Pre and Post Analysis.
**Sample** **size****:** 30 patients
**Method of collection of data**:
Clinical history and clinical examination
Laboratory investigations
**Selection of patients:**
**Inclusion criteria:**
1) Parous women in the age group of 30-60 years
2) First & second degree uterovaginal prolapse
**Exclusion criteria:**
1) Patient with procidentia, congenital elongation of cervix, huge fibroid/cyst, polyp and chronic inversion of uterus.
2)Pregnant & lactating women
3) Uncontrolled diabetes and hypertension
4) Malignancies
**Assessment of parameters:**
**Subjective parameters:** Mass per vaginam, Urinary incontinence, Low backache, Lower abdominal discomfort and Defecation difficulties.
**Objective parameters:** Baden-walker halfway system to assess the degree of prolapse, VAS scale to assess pain and FPFQ score for symptoms and quality of life.
**Intervention:** Unani formulation for *Aabzan* and *Humool along with dry cupping.*
**Ingredients:**
*Gul e surkh* (*Rosa Damascena*) - 6.6gms
*Izkhar* (*Cymbopogon citratus*) – 6.6gms
*Habbul-ul-Aas* (*Myrtis Communis*) – 6.6gms
*Aqaqia* (*Acacia Arabica*) -5gms
*Aabzan* of *Gul e surkh*, *Izkhar*, *Habb-ul-Aas*
*Hamūl* of *Aqaqia*
Dry cupping19 below the umbilical region alternate days for 15minutes.
**Method of preparation:** Equal amount of*Gul e surkh*, *Izkhar,* *Habb-ul-aas* will be coarsely grounded and dispensed in self-locking pack. *Aqaqia* will be grinded to make fine powder and dispensed.
**Route of administration, dosage and duration:** *Aabzan* with the decoction of *Gul e* *surkh, Izkhar* and *Habb-ul-aas* (20gms boiled in 1 litre of water and 3 litres of water will be added) will be done followed by *Hamūl* of 5gms of *Aqaqia* mixed with water and kept in vagina for 8 weeks except during menses. Dry cupping will be done after *Hamūl* every alternate days for 15minutes.
**Duration of protocol therapy**: 8 weeks except during menses
**Procedure of study:** Diagnosed cases of first and second degree of uterovaginal prolapse will be randomly allocated and written informed consent will be obtained. Locally , 20gms of coarsely powdered *Gule surkh, Izkhar* and *Habb-ul-Aas* will be boiled in 1 litre of water and 3 litres of water will be added and patient will be asked to do *Aabzan* . Later *Hamūl* of 5gms of *Aqaqia* mixed with water will be kept per vaginam for 8 weeks except during menses followed by dry cupping below the umbilical region every alternate day for 15minutes .Baden-Walker halfway system will be used to assess degree of prolapse .VAS scale will be used to assess pain. FPFQ score will be used to assess symptoms and quality of life.
**Follow-up:**
**During and after trial:** Follow up of the patient will be done every 15days for 2 months and after 1 month following completion of trial
**Duration of study**: One and a half year
**Withdrawal criteria:**
Failure to follow protocol therapy
The case in which adverse drug reaction is noticed
**Informed consent:**
Patients fulfilling the inclusion criteria will be given the information sheet having details regarding the nature of study and the procedure to be used. Patients will be given enough time to go through the study details mentioned in the information sheet. They will be given an opportunity to ask any question and if they agree to participate in the study, they will be asked to sign the informed consent form.
**Assessment of efficacy:** The efficacy of the test drugs will be assessed by Baden-Walker halfway system to assess degree of prolapse, FPFQ questionnaire for relief of pelvic symptoms and to assess the quality of life. VAS scale to assess pain.
**Primary outcome:** changes in objective parameters
**Secondary outcome:** changes in subjective parameters
**Assessment of the safety:**
Clinical sign and symptoms
Laboratory Investigations
**Adverse drug documentation:** Any adverse reaction of the drug will be documented
**Documentation**: The record will be submitted to the department after completion of study.
**Statistical analysis**: The appropriate tests will be applied to analyse the data. The descriptive statistical analysis will be used in the study. Results on continuous measurements will be presented in mean (SD) and results on the categorical measurements will be presented in number (%) with 5% level of significance and 95% confidence interval.
**Does the study require any investigation or intervention to be conducted on patients or other human animals?** Yes.
**Investigations**:
**Pre-test**: CBC, ESR, RBS, Urine routine, USG abdomen-pelvis, pap smear
**Has ethical clearance been obtained from your institution in case of 7.3 –** Ethical clearance obtained vide No. NIUM/IEC/2020-21/012/ANQ/03, Dated: 14.07.2021.
**List of references**:
1- Shameem I, Rahman FN. Concept of uterovaginal prolapse in unani system of medicine-an updated review.
2- Doshani A, Teo RE, Mayne CJ, Tincello DG. Uterine prolapse. Bmj. 2007 Oct 18;335(7624):819-23.
3- Harjit, Johnson S. ‘’An exploratory study to assess the knowledge regarding uterine prolapse and its prevention among staff nurses in Christian Medical College and Hospital, Ludhiana, Punjabâ€. IJDR,2019;09(02):25925-25928
4- Mishra U, Poonam, Prasad U.Pelvic organ prolapse – four year review from IGIMS, Patna, international journal of contemporary medical research 2019;6(10):J1-J4
5- MA. Akseer Azam (Al Akseer). New Delhi,Idara kitabul shifa:2011:793-95
6- Shivanandaiah TM, Indudhar TM. Lajjalu treatment of uterine prolapse. Journal of Ayurveda and integrative medicine. 2010 Apr;1(2):125.
7- Chang YJ, Chen WC, Chiang JH, Su YC, Tsai KS, Man KM, Tsai MY, Chen YH, Chen HY. Traditional Chinese medicine decreases the obstructive uropathy risk in uterovaginal prolapse: A nationwide population-based study. Medicine. 2018 Sep;97(38).
8- Vergeldt TF, Weemhoff M, IntHout J, Kluivers KB. Risk factors for pelvic organ prolapse and its recurrence: a systematic review. International urogynecology journal. [2015](tel:2015) Nov;26(11):[1559-73](tel:1559-73).
9- American college of Obstetrician & Gynaecologists. Pelvic organ prolapses. ACOG Practice Bulletin No.185.Obstet Gynecol 2017;130(5):234-250
10- Wiegersma M, Panman CM, Kollen BJ, Berger MY, Lisman-Van Leeuwen Y, Dekker JH. Effect of pelvic floor muscle training compared with watchful waiting in older women with symptomatic mild pelvic organ prolapse: randomised controlled trial in primary care. Bmj. 2014 Dec 22;349.
11- Razi ABZ. Al Hawi Fil Tib,Vol IX.New Delhi:CCRUM;2001;23
12- Khan A.Muhit I Azam,Vol I, IV.1ST edition.New delhi :CCRUM;2018:191-94,263-67,376-78,222-27
13- Ansari S, Zeenat F, Ahmad W, Ahmad I. Therapeutics and pharmacology of Gul-e-Surkh (Rosa damascena Mill): An important Unani drug.
14- Bastani P, Mallah F, Fard LR. Adaptation of Pelvic Organ Prolapse Guideline in Iranian Adult Women. Advances in Bioscience and Clinical Medicine.[2018](tel:2018) Feb13;6(1):[6-10](tel:6-10).
15- Sina I. Al Qanoon Fil Tib.New Delhi, Idara kitabul shifa; 2010:1100
16- Persu C, Chapple CR, Cauni V, Gutue S, Geavlete P. Pelvic Organ Prolapse Quantification System (POP–Q)–a new era in pelvic prolapse staging. Journal of medicine and life. 2011 Feb 15;4(1):75.
17- Zuchelo LT, Bezerra IM, Da Silva AT, Gomes JM, Júnior JM, Baracat EC, de Abreu LC, Sorpreso IC. Questionnaires to evaluate pelvic floor dysfunction in the postpartum period: a systematic review. International journal of women’s health. 2018; 10:409.
18- Mehta P, Dhapte V. Cupping therapy: A prudent remedy for a plethora of medical ailments. Journal of traditional and complementary medicine. 2015 Jul 1;5(3):127-34
19- Arzani HA.Tibbe Akbar.(Urdu translation Hk.Mohd Hussain).Deoband:Faisal Publications;(YNM):605-607.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 30
• Parous women in the age group of 30-60 years • First & second degree uterovaginal prolapse.
- 1)Patient with procidentia, congenital elongation of cervix, huge fibroid/cyst, polyp and chronic inversion of uterus.
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- Pregnant & lactating women 3) Uncontrolled diabetes and hypertension 4)Malignancies.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in baden walker halfway system, vas scale, Female pelvic floor questionnaire Once in 2 weeks and for 8 weeks
- Secondary Outcome Measures
Name Time Method Changes in Mass per vaginam, Urinary incontinence, Low backache, Lower abdominal discomfort and Defecation difficulties. Once in 15days and pre and post test
Trial Locations
- Locations (1)
National Institute of unani medicine, kottigepalya, Magadi main road
🇮🇳Bangalore, KARNATAKA, India
National Institute of unani medicine, kottigepalya, Magadi main road🇮🇳Bangalore, KARNATAKA, IndiaDr Fathima begum HPrincipal investigator9790743790dr.fathimabegum95@gmail.com