EFFICACY OF ABZAN (SITZ BATH) IN THE MANAGEMENT OF ABNORMAL VAGINAL DISCHARGE : AN OPEN LABELLED INTERVENTIONAL CLINICAL TRIAL
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- improvement in abnormal vaginal discharge and or any associated symptoms assessed by VAS
研究概览
简要总结
Abnormal Vaginal discharge is common symptom experienced by women of all ages,1 but it predominantly affects more in the reproductive age group and is frequently the initial indication of most of the Reproductive tract infections (RTIs).2,3 And it is the second most common problem after abnormal uterine bleeding.1 About 20 to 25% of women visiting Gynaecology OPDs, report vaginal discharge and leucorrhoea, although in some of cases the discharge may be physiological but more than 60% of cases attributed to vaginal or uterine infections i.e. Abnormal vaginal discharge caused by parasites, bacteria and Fungi.4,5 According to available Indian data it has been estimated 26.3% women in rural area are having abnormal vaginal discharge 6. The presence of abnormal vaginal discharge can stem from both physiological and pathological with the later predominantly linked to infectious origin often attributed to, bacterial, fungal and parasitic infections such as bacterial vaginosis, candidiasis and trichomonas vaginalis 7,8,9. The prevalence of infections is ranging from 23- 29% of bacterial vaginosis globally and in India it ranges from 17.8-63.7% 10,11. In the same manner, 30-50% of women affected by vulvovaginal candidiasis at least once in a lifetime and it also constitute the prevalence of 10-35% in India 12 . Similarly in Global and Indian scenario, the prevalence of
trichomoniasis is 8.1% and 6-8% respectively.13
Abnormal vaginal discharge can be categorised as change in colour, consistency, volume or odour and may be associated with symptoms such as itching, soreness, dysuria, pelvic pain, low backache etc.13,15 As we have already discussed that chiefly it is of infectious in origin so in majority of settings they received treatment for bacterial vaginosis, candidiasis and trichomoniasis.16
Study shown that RTI can lead to numerous severe outcomes particularly affecting women such as pregnancy complications, congenital infection, pelvic inflammatory diseases, infertility, ectopic pregnancy, chronic pain and increased HIV transmission risk. These health issues have substantial economic and social implication for individuals and communities, impacting productivity and quality of life.15
In conventional medicine, abnormal vaginal discharge is often treated with anti- microbial medications, the specific treatment depends on underlying cause of the discharge. So the overuse of antibiotics and antifungals can lead to antibiotic resistance and distrupts the balance of normal vaginal flora paving the way for fungal infections like candida albicans. This can seriously impact treatment effectiveness and worsen infections and even affect reproductive ability that’s why it is crucial to promote judicial use of antibiotics and explore alternative treatment.
Sailan-al-Raham, a term frequently used to describe abnormal vaginal discharge in classical Unani writings is defined as excessive secretions from the female genital tract. Azam Khan in his book Al- Akseer mentioned that this secretion could be pathological or a typical physiological event. He further mentioned that Physiological discharge is called as Sailan-al-Mani. The Cause behind physiological vaginal discharge in Unani literature is weakness of Quwwat-e-ghadhiya while pathological discharge is due to taffun (infection) or ghalba-e-khilt (abnormal temperament).17,18
Unani system of medicine works on the theory of temperament and is composed of four mode of treatment Ilaj bil ghiza, Ilaj bit tadbeer, Ilaj bil dawa , Ilaj bil yad. Ilaj bit tadbeer (Regimenal therapy) itself composed of number of modalities like Hijama, Dalk, Hammam, Riyazat, Ishal, Qai, Abzan etc. Eminent Unani physicians like, Zakariya Razi, Ismail Jurjani, Jalinus and many other recommend Abzan with Qabiz and Habis adviya (mazo, jufte baloot, phitkari, khabasul hadeed) in the treatment of Sailan-al-Raham.19 So, it is high time to look for alternative options for the treatment of Sailan-al- Raham which are not only better, and safer but can also prevent recurrence.
In the light of the aforementioned facts, I am determined to conduct a clinical trial to appraise the efficacy of Abzan in management of Sailan-al-Raham.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- Female
入选标准
- •Married women between 18 to 50 years of age with mild to moderate abnormal vaginal discharge.
- •Women presenting with abnormal vaginal discharge and/or associated with low backache, burning micturition, lower abdominal pain, dysuria, dyspareunia, vulvar itching, and irritation.
- •Patient who will give consent and able to do follow up.
排除标准
- •1.Pregnant, lactating, and unmarried women.
- •Patient suffering from severe systemic illness.
- •Patients with abnormal uterine bleeding or vaginal bleeding, ulceration, unhealthy cervix, genital prolapse or genital malignancy.
- •Patient who have received either CAM therapy or antibiotics, antifungals and antiprotozoals or use of vaginal douches in last 2 weeks.
- •Patients with Syphilis, Gonorrhoea, HIV.
- •H/O oral contraceptive pills use within 1 week and IUCD insertion within 3 months of enrolment.
结局指标
主要结局
improvement in abnormal vaginal discharge and or any associated symptoms assessed by VAS
时间窗: 7TH AND 14TH DAY
Improvement in the quality of life by (SF 12)
时间窗: 7TH AND 14TH DAY
次要结局
- Vaginal pH(Whiff test)
研究者
Khushnuma Parveen
State Unani Medical College
