Treatment of Malarial Fever by Unani medicine Malerian

Phase 3

Not yet recruiting

• Conditions: Plasmodium malariae malaria without complication,

• Registration Number: CTRI/2020/05/025253
• 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 **ḤummÄ AjÄmiyya (Malarial Fever)****.** After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria.  The patients will be assessed at every 7 and 14 day.  This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 2 weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy

**Composition of Malerian**

| | | | |

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

|**S. No.**

**Ingredients**

**Scientific Names**[[n1]](file:///C:/Users/DR.%20PRADEEP/Desktop/Protocols/Final%20Protocols%202018-19/Final%20malaria%20protocol-15.03.19.docx#_msocom_1)

**Quantity**

|1.

Barg-e-Gaozaban

*Borago officinalis*

1kg

|2.

Turbud Akabarabadi

*Operculinaturpethum*

1kg

|3.

ChiraitaTalkh

*Swertiachirata*

1kg

|4

Gul-e-Nilofar

*Nymphaea alba*

1kg

|5

Gul-e-Surkh

*Rosa damascene*

1kg

|6

Tukhm-e-Kasni

*Cichoriumintybus*

1kg

|7

Tukhm-e-Khayarain

*Curcumissativus*

1kg

|8

TurshaKibreet

Sulphur

350g

|9

HeeraKasees

Ferrous sulphate

350g

|10

Afsanteen

*Artemisia absinthium*

350g

|11

Sat-e-Leemu

*Citrus limon*

180g

|12

QandSafaid

Sugar

47.50 kg

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-05-15
• Study Start: 2020-05-21

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients of either sex of age 18-65 years.
• Presence of axillary temperature ≥ 37.5°C (99.5 o F) or oral temperature of > 38 o C (100.4 o F) or history of fever during the past 24 hours.
• Mono-infection with P.
• vivax confirmed by either positive blood smear (i.e. no mixed infection) or RDT (Rapid Diagnostic Test).

Exclusion Criteria

• Any evidence of severe malaria that would require hospitalization for treatment i.e. including: impaired consciousness, respiratory distress, severe anaemia (Hb<5),multiple seizures, frequent vomiting/ inability to swallow tablets, prostration, jaundice, hypotension abnormal bleeding or hypoglycaemia.
• to WHO definition) 2.
• Mixed or mono-infection with Plasmodium species other than P.
• vivax detected by microscopy.
• Patients associated with other known conditions requiring long term treatment like TB, AIDS, diabetes, hypertension etc.
• Reported allergy to any antimalarial drugs, including sulfa and artemisinin drugs.
• Patients with Glucose-6-phosphate dehydrogenase deficiency 6.
• Pregnant and lactating females.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in signs and symptoms of ḤummÄ AjÄmiyya (Malarial Fever)	2 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 (1)

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

Regional Research Institute of Unani Medicine (RRIUM)

🇮🇳Aligarh, UTTAR PRADESH, India

Dr Misbahuddin Azhar

Principal investigator

8802140093

misbahuddindr1980@gmail.com