Treatment of Amenorrhea (absence of monthly menstrual periods) by Unani medicine Habb-e-Mudir

Phase 3

Not yet recruiting

• Conditions: Secondary amenorrhea,

• Registration Number: CTRI/2019/02/017786
• Lead Sponsor: Central Council for Research in Unani Medicine CCRUM

Brief Summary

This study is designed as a multicentric open trial in patients with **IhÌ£tibÄs al-Tamth (Amenorrhea).** After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria.  The patients will be assessed clinically for three consecutive cycles during treatment and twocycle after treatment. During this period, menstrual cycle pattern wereassessed. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 3months. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy. 

**Composition of Habb-e-Mudir**

| | | | |

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

|**S.No.**

**Ingredients**

**Scientific Name**

**Quantity**

|

Sibr

*Aloe barbadensis Linn.*

2 gm

|

Hara Kasees

*Ferrous sulphate*

1 gm

|

Zafran

*Crocus sativus Linn.*

1 gm

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-02-21
• Study Start: 2019-02-28

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 240

Inclusion Criteria

• Married /unmarried patients in the age group of 18-40 years.
• Patients with secondary amenorrhoea.

Exclusion Criteria

• Patients with Primary Amenorrhea and primary ovarian failure 2.
• Patients with Hyperprolactinaemia 3.
• Patients with any systemic illness and malignancy 4.
• Pregnant and lactating woman 5.
• Patients taking OCP’s / IUCD.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in signs and symptoms of IhÌ£tibÄs al-Tamth (Amenorrhea)	3 months

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)

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

Regional Research Institute of Unani Medicine (RRIUM); 🇮🇳 Mumbai, MAHARASHTRA, India

Central Research Institute of Unani Medicine (CRIUM)

🇮🇳Hyderabad, TELANGANA, India

Dr Arifa Khatoon

Principal investigator

9450023521

drarifakhan40@gmail.com

Dr Arzeena Jabeen

Principal investigator

9032519286

aarzu763@gmail.com