Treatment of Anaemia (Decrease in Red Blood Cells or Haemoglobin in Blood) with Unani medicine Habb-e-Khubs-ul-Hadeed

Phase 3

Not yet recruiting

• Conditions: Iron deficiency anemia, unspecified,

• Registration Number: CTRI/2019/02/017822
• Lead Sponsor: Central Council for Research in Unani Medicine CCRUM

Brief Summary

This study is designed as a multicentric open trial in patients with **Sū’ al-Qinya (Anaemia).**After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria.  The patients will be assessed clinically fortnightly.  This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 12 weeks.. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy

**Composition of Investigational Drug**

| | | | |

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

|**S. No.**

**Ingredients**

**Botanical Name**

**Quantity**

|1.

Khabs-ul-Hadeed

*Iron Oxide*

400 g

|2.

Habb-ul Rashad

*Lepidium Sativum*

80 g

|3.

Tukhm-e-Gandana

*Allium ascalonicum*

10 g

|4.

Tukhm-e-Jirjeer

*Eruca sativa*

10 g

|5.

Tukhm-e-Karafs

*Apium graveolens*

10 g

|6.

Tukhm-e-Gazar

*Daucus carota*

10 g

|7.

Tukhm-e-Turb

*Raphanus sativa*

10 g

|8.

Tukhm-e-Hulba

*Trigonella foenum- graecum*

10 g

|9.

Tukhm-e-Piyaz

*Allium cepa*

10 g

|10.

Heel Khurd

*Elettaria cardamum*

10 g

|11.

Aab-e-Gandana

*Allium ascalonicum*

Q.S.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-28
• Last Update Posted: 2020-12-05

Recruitment & Eligibility

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

Inclusion Criteria

• · Patients having mild (10.0-11.9 g/dL) to moderate (7.0-9.9 g/dL ) Anaemia · Patients of either sex in the age group 18-65 years.
• · Patients not taking any other drugs for Sū’ al-Qinya (Anaemia).

Exclusion Criteria

• Pregnant and lactating women 2.
• Patients having severe Anaemia (below 7gm/dl) 3.
• Patients having occult blood positive on stool examination.
• Patients with chronic diseases requiring long-term treatment such as DM, T.B., HIV infection, leukemia, endocrine disorders, Haemorrhagic diathesis (hemophilia, ITP), bleeding piles, menorrhagia, metrorrhagia or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute a risk when taking study drug or could interfere with the interpretation of data.
• Patients with concurrent serious hepatic, cardiac, renal or pulmonary dysfunction.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in signs and symptoms of Sū’ al-Qinya (Anaemia)	12 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)

Central Research Institute of Unani Medicine (CRIUM); 🇮🇳 Lucknow, UTTAR PRADESH, India

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

Central Research Institute of Unani Medicine (CRIUM)

🇮🇳Lucknow, UTTAR PRADESH, India

Dr Mohammad Nafees

Principal investigator

9140705710

mnkccrum@yahoo.com