Vaginal discharge is common and often seen in patients attending gynaecology clinics. Women normally have some vaginal discharge, which may be more pronounced during certain phases of the menstrual cycle, during and after sexual activity, and during pregnancy and lactation. In general, women only seek care for vaginal discharge if they perceive it as unusual, or if it causes itching or discomfort. In the vaginal discharge syndrome, symptoms are abnormal vaginal discharge, vaginal itching, painful urination and pain during sexual intercourse. Based on etiology it is categorized as infectious and non-infectious vaginal discharge.

 Abnormal/ Infectious vaginal discharge is defined as discharge that is different from usual with respect to colour/ odour/consistency (discoloured or purulent or malodorous).  It is often associated with vulvar pruritus or pain with intercourse (dyspareunia), or painful or difficult urination (dysuria) or lower abdominal pain. Often, vaginal discharge indicates vaginitis due to trichomoniasis, STIs (Sexually Transmitting Infections), or two naturally occurring infections; bacterial vaginosis and candidiasis. The prevalence of the infections causing vaginitis is high in many areas. These infections generally do not lead to major complications and can be easily treated. However, the lower genital tract infections are sometimes difficult to diagnose and manage as they carry a polymicrobial etiology. Cervicitis though less common may sometimes cause vaginal discharge. If left untreated, the infections causing cervicitis can lead to major complications, such as pelvic inflammatory disease.

Unani classical manuscripts elucidate the concept of vaginal discharge. It is mentioned as leucorrhoea (Sailan ul-Mani), an excessive flow of normal discharge from the uterus and vaginal discharge (Sailan ur-Rehm) as an infected discharge pouring out from the uterus. Physiologically, vaginal discharge is also noted at the time of sexual arousal; however, if the discharge is seen without sexual arousal, then the cause of the discharge is the weakness of the uterine digestive faculty (Du’fe Quwwat-i-Hadima al-Rehm). The various aetiological factors of abnormal vaginal discharge are attributed to the dominance of humour (Ghalaba-i-Akhlat) The imbalance in the four humors leads to abnormal vaginal discharge, reproductive tract infections like metritis (Waram e-rehm) and vaginitis (Waram al-Mahbil). This can also lead to the development of certain dreadful diseases, like syphilis (Aatshak), gonorrhea, and so on. It has also been mentioned in the texts that kasrate aurame rehm (uterine inflammations) and presence of morbid material within the uterine vessels causes sailan ur rehm. The discharge may also occur due to the weakness of Quwwate jazeba.  It has further been mentioned that sometimes the waste matter (fudlaat) of the body is diverted towards the uterus in order to eliminate them by natural means (istefragh). Unani scholars have used swab color assessment to diagnose the dominance of Humor (galbae khilt). The swab may turn white, yellow, red, or black when kept in the vagina overnight indicating the dominance of abnormal humor. 

The unani physicians have also classified sailan ur rehm into four types based on their pathophysiology; Sailan-ur -rehm Damwi, Sailan-ur-rehm-Safrawi, Sailan-ur- rehm Balghami, Sailan-ur-rehm Sawdavi. The management of sailan-ur-rehm depends on the diagnosis of Galba-e -Khilt and hence Ilaj bil Zid is applied. A number of Unani drugs (single as well as compound formulations) have been mentioned in the classical texts for the management such as moocharas (Bombax malabaricum), mazu (Quercus infectoria), baboona (Matricaria chamomilla) gile makhtoom (Sealing clay), gile Armani (Armenian bole), gul naar (Punica granatum), tukhme khatmi (Althea officinalis), muqil (Commiphora mukul), shibe yaman (Potassium aluminium sulphate), habul aas (Myrtus communis) etc.  Compound formulations like Marhame dakhilyoon have been in extensive use for the same.

Out of all the available Unani drugs (single as well as compound), a pharmacopeial formulation comprising of gule baboona (Matricaria chamomila), mako (Solanum nigrum), marzanjosh (Origanum majorana) and qaisoom (Achillea fragantissima) have been chosen to test for the research study. 

The importance of vaginal pH and vaginal flora in maintaining a well-balanced vaginal ecosystem is well known (SOPHY Project Vol. 60 2008) Women experience various symptoms of vaginal discharge syndrome throughout their reproductive life which can have a significant impact on their quality of life. Frequent times, the vaginal discharge is non-infectious, due to excessive perspiration, epilation of pubic hair via creams or razors, urinary or faecal incontinence and poor intimate hygiene etc. The discharge could also be due to cervical ectropion and in cases of chronic cervicitis.  In response to the symptom, women use a variety of intimate hygiene products available as Over the Counter (OTC) as part of their daily cleansing routine. Further, RCOG (Royal College of Obstetricians and Gynecologists) and MECA (Middle East and Central Asia) have suggested in their guidelines use of daily vulva cleansing with a gentle hypoallergenic liquid wash. However, the over-the-counter intimate hygiene products lack ample research on their safety on the vaginal mucosal biome and efficacy for the management of non-infectious causes of vaginal discharge.

In the unani system of medicine, extensive use of local therapy viz; use of douches, local perineal washes, pessary and suppository treatments are mentioned for vaginal discharge. For the same various number of single and compound drugs are available which have Muhallile auram (anti-inflammatory), Dafae taffun (antiseptic), Habis wa Qabiz (Astringents) properties. These drugs will alter the disturbed humoral milieu locally and therefore improve the vaginal health of the female. The drugs which are mentioned for the use in vaginal discharge syndrome include mocharas (Bombax malabaricum), mazoo (Quercus infectoria),  baboona (Matricaria chamomilla), gile makhtoom (Sealing clay). gile armani (Armenian bole), gul naar (Punica granatum), tukhme khatmi (Althea officinalis), muqil (Commiphora mukul), shibe yamani (Potassium aluminium sulphate), habul aas (Myrtus communis), kundru (Boswellia serrata) etc. Compound formulations like safoofe sailan, majoon mocharas, majoon muqawwie reham etc are being used extensively for the management of sailanur reham. Apart from these various ointments are also used locally to manage abnormal vaginal discharge viz marhame dakhilyoon. After thorough literature review the test drug gule baboona (Matricaria chamomila), mako (Solanum Nigrum), marzanjosh (Origanum majorana) and qaisoom (Achillea fragantissima) have been chosen for the research study.

We hypothesize that the local use of the test drug (vaginal wash) may be useful in regulation of vaginal health by balancing the altered humoral milieu, as well as lower the vaginal pH. Based on this, the present randomized placebo-controlled trial is aimed to assess the efficacy of Unani formulation in non-infectious vaginal discharge in reproductive aged females.