| 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
|
|
|
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
|
|
|
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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