To evaluate the Safety and efficacy of Unani formulation Majoon Supari paak in SayalÄn al-Rahim (Leucorrhoea)

Phase 2

Recruiting

• Conditions: Other specified noninflammatory disorders of vagina,

• Registration Number: CTRI/2015/10/006290
• Lead Sponsor: Central Council for Research in Unani Medicine New Delhi

Brief Summary

his study is designed as a multicentric open trial in patients with **SayalÄn al-Rahim (Leucorrhoea)** After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria.  The patients will be assessed clinically at every two weeks.  This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 4 weeks. . Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.

Composition of **Majoon Supari paak**

1.      KhurmaKhushk                                                                                  500g

2.      Fofil                                                                                                    250g

3.      Majeeth                                                                                               125g

4.      Sheere Gao                                                                                         10litres

5.      Maghze Badam Shireen                                                                     500g

6.      NishastaGandum Biryan                                                                    250g

7.      Samaghe Arabi Biryan                                                                       250g

8.      Arade Moong                                                                                     125g

9.      Raughane Zard                                                                                  1kg

10.  Qande Safaid                                                                                     3kg

11.  Khare Khask Khurd                                                                           500g

12.  Samaghe Dhak                                                                                   250g

13.  Maghze Narjeel Khushk                                                                    250g

14.  SalabMisri                                                                                          55g

15.  Darchini                                                                                              55g

16.  Qaranfal                                                                                              55g

17.  Heelkhurd                                                                                          55g

18.  Zanjabeel                                                                                             55g

19.  Jauzbuwa                                                                                           25g

20.  Gule Supari                                                                                        15g

21.  Gule pista                                                                                           15g

22.  Poste Kachnaal                                                                                  10g

23.  Poste Mughilaan                                                                                10g

24.  Poste Sankhaholi                                                                                10g

25.  Zafraan                                                                                                50g

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-06
• Last Update Posted: 2019-02-26

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• •Female patients in the age group of 13-45 years.
• •Patients having excessive white discharge with or without any of the following associated symptoms •Waja‘ al-Zahr (Backache) •Naqahat (General Weakness) •Faqr al-Dam (Anaemia) (8-10 mg % in females).

Exclusion Criteria

• •Patients having acute/ acute on chronic/Chronic PIDs (as per the CDC Diagnostic Criteria attached as an annexure-IV) •Patients on long-term medications.
• •Patients on Oral Contraceptives/IUDs. •Patients taking hormonal therapy.
• •Any abnormal condition on p/s Examination.
• •Pregnant and lactating women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
improvement in the sign and symptoms of SayalÄn al-Rahim (Leucorrhoea)	4 weeks

Secondary Outcome Measures

Name	Time	Method
Hematological and biochemical assessments for safety	4 weeks

Trial Locations

Locations (3)

Central Research Institute of Unani Medicine (CRIUM), Hyderabad; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

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

Regional Research Institute of Unani Medicine (RRIUM), Patna; 🇮🇳 Patna, BIHAR, India

Central Research Institute of Unani Medicine (CRIUM), Hyderabad

🇮🇳Hyderabad, ANDHRA PRADESH, India

Dr Syeda Khadeerunnisa

Principal investigator

9397953137

syedakhadeerunnisa@criumhyderabad.net