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CTRI Number  CTRI/2025/07/091753 [Registered on: 25/07/2025] Trial Registered Prospectively
Last Modified On: 24/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Single Arm Study 
Public Title of Study   EFFICACY OF SITZ BATH IN THE MANAGEMENT OF ABNORMAL VAGINAL DISCHARGE  
Scientific Title of Study   EFFICACY OF ABZAN (SITZ BATH) IN THE MANAGEMENT OF ABNORMAL VAGINAL DISCHARGE : AN OPEN LABELLED INTERVENTIONAL CLINICAL TRIAL 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Khushnuma Parveen 
Designation  PG Scholar 
Affiliation  State Unani Medical College  
Address  State Unani Medical College and HAHRDM Hospital Himmatganj Prayagraj

Allahabad
UTTAR PRADESH
211016
India 
Phone  7905988284  
Fax    
Email  khushnumazaheer7905@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Jamal Akhtar 
Designation  Professor 
Affiliation  State Takmeel ut tib 
Address  6th Floor Indira Bhawan

Lucknow
UTTAR PRADESH
226001
India 
Phone  8052142175  
Fax    
Email  drjamalakhtar@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Khushnuma Parveen 
Designation  PG scholar 
Affiliation  State Unani Medical College  
Address  State Unani Medical College and HAHRDM Hospital Himmatganj Prayagraj

Allahabad
UTTAR PRADESH
211016
India 
Phone  7905988284  
Fax    
Email  khushnumazaheer7905@gmail.com  
 
Source of Monetary or Material Support  
State Unani Medical College and Hospital Prayagraj 211016,Utter Pradesh,India 
 
Primary Sponsor  
Name  State Unani Medical College Himmatganj Prayagraj 
Address  Department of Ilaj-Bit-Tadbeer State Unani Medical College and Hospital Himmatganj Prayagraj Utter Pradesh 211016 India  
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 Khushnuma Parveen  State Unani Medical College and Hospital  Department of Ilaj Bit Tadbeer room no 2 ground floor Allahabad
Allahabad
UTTAR PRADESH 
07905988284

khushnumazaheer7905@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N898||Other specified noninflammatory disorders of vagina, (2) ICD-10 Condition: N898||Other specified noninflammatory disorders of vagina,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Abzan(Sitz bath)  Patients will be advised to take a Abzan (sitz bath) with Polyherbal decoction (joshanda ) daily for 14 days. Patients who are going to take Abzan (sitz bath) will have to follow these steps, an adequate size tub should be taken and cleaned by adding 2 table-spoon of bleach with half gallon of water and should be scrubbed and rinsed thoroughly, then the tub will be filled with 5 litres of warm water but make sure that water should not be hot enough to cause any burns or discomfort. Now the joshanda will be poured into the tub. Then the patients will be advised to step in the tub for 20 mins by taking their bottom wear off exposing their genitalia as well as by bending their knees or dangling their legs over the sides of the tub to keep them out of water altogether. After getting out of the tub the patients will have to pat themselves dry with a clean cotton towel. Duration of protocol therapy: 14 days Duration of study: 18 months Follow-Ups: on 7th and 14th day. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  Married women between 18 to 50 years of age with mild to moderate abnormal vaginal discharge.
2. Women presenting with abnormal vaginal discharge and/or associated with low backache, burning
micturition, lower abdominal pain, dysuria, dyspareunia, vulvar itching, and irritation.
3. Patient who will give consent and able to do follow up. 
 
ExclusionCriteria 
Details  1.Pregnant, lactating, and unmarried women.
2. Patient suffering from severe systemic illness.
3. Patients with abnormal uterine bleeding or vaginal bleeding, ulceration, unhealthy cervix, genital
prolapse or genital malignancy.
4.Concomitant skin disease at the application site like herpetic vesicles, genital psoriasis, tinea cruris
contact dermatitis etc.
5. Patient who have received either CAM therapy or antibiotics, antifungals and antiprotozoals or use
of vaginal douches in last 2 weeks.
6. Patients with Syphilis, Gonorrhoea, HIV.
7. H/O oral contraceptive pills use within 1 week and IUCD insertion within 3 months of enrolment. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
improvement in abnormal vaginal discharge and or any associated symptoms assessed by VAS
Improvement in the quality of life by (SF 12) 

7TH AND 14TH DAY  
 
Secondary Outcome  
Outcome  TimePoints 
Vaginal pH
Whiff test
Vaginal wet mount 
7th, 14th day 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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/ Phase 3 
Date of First Enrollment (India)   11/09/2025 
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  
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.

 
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