Treatment of Abnormal Excessive Vaginal Discharge by Unani medicine Sailani

Phase 3

Not yet recruiting

• Conditions: Noninflammatory disorder of vagina, unspecified,

• Registration Number: CTRI/2020/02/023428
• Lead Sponsor: Central Council for Research in Unani Medicine CCRUM New Delhi

Brief Summary

This study is designed as a multicentric open trial in patients with **SayalÄn al-Rahim (Abnormal Excessive Vaginal Discharge)****.** After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be treated with Unani pharmacopoeial formulation **Sailani two tablets twice** daily with water for four weeks.  The patients will be assessed at every two weeks. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be four weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.

**Composition of *Sailani***

| | | | |

| --- | --- | --- | --- |

|**S.No.**

**Ingredients**

**Scientific Name**

**Quantity**

| Kushta Baize Murgh

(Hen’s Egg Shell) Calcinate

200 g

| Kushta Sadaf

(*Pinctada margaritifera*) pearl-shell calcinate

280 g

| Maghz-e-Tukhm-e-Tamar Hindi Biryan

*Tamarindus indica*

1.5 kg

| Kamarkas (Samag dhak)

*Butea monosperma*

6.50 kg

| Taj Qalmi

*Cinnamomum cassia Blume*

6.50 kg

| Dana Ilaichi kalan

*Amomum subulatum Roxb*

3.25 kg

| Tabasheer Mehlool

*Bambusa arundinacea Willd*

3.25 kg

| Busud ahmar

*Corallium rubrum*

3.25 kg

| Satawar

*Asparagus racemosus Willd.*

3.25 kg

| Mocharas

*Salmalia malabarica*

3.25 kg

| Phali babool

*Acacia arabica*

3.25 kg

| Kishneez khushk

*Coriandrum sativum*

3.25 kg

| Khurfa siyah

*Portulaca oleracea*

3.25 kg

| Mazu sabz

*Quercus infectoria*

3.25 kg

| Paraffin

---

1 kg

| Sang-e-jarahat

***Hydrated Magnesium Silicate***

1.50 kg

| Qand safaid

*Sugar (Saccharum officinarum Linn.)*

24 kg

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-02-17
• Study Start: 2020-02-28

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• Sexually active women of age group 18 – 45 years.
• 2.All women complaining of vaginal discharge.
• 3.Associated symptoms: I.
• Vulval Itching II.
• Low Backache III.
• Generalised weakness IV.
• Burning Micturition V.
• Abnormal vaginal odour 4.Patients willing to take part in study.

Exclusion Criteria

• Patient more than 45 years of age.
• Menopausal, Pregnant and Lactating women.
• Known cases of any systemic illness like hypertension, diabetes mellitus.
• Patients with H/O fibroid, polyp, ovarian tumour or cyst, uterine-prolaps and malignancy.
• Patients using OCPs or intrauterine devices.
• Known cases of HIV, Syphilis, Gonorrhoea.
• Patients having acute/acute-on chronic/Chronic PID as per CDC Criteria.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in signs and symptoms of SayalÄn al-Rahim (Abnormal Excessive Vaginal Discharge)	4 weeks

Secondary Outcome Measures

Name	Time	Method
Haematological and biochemical assessment for safety assessment	Investigations will be done at baseline and end of treatment

Trial Locations

Locations (2)

Clinical Research Unit (CRU); 🇮🇳 Bhopal, MADHYA PRADESH, India

Regional Research Institute of Unani Medicine (RRIUM); 🇮🇳 Aligarh, UTTAR PRADESH, India

Clinical Research Unit (CRU)

🇮🇳Bhopal, MADHYA PRADESH, India

Dr Afshan Qaiser

Principal investigator

9074743166

afshan.qaiser@gmail.com