| CTRI Number |
CTRI/2020/05/025253 [Registered on: 20/05/2020] Trial Registered Prospectively |
| Last Modified On: |
15/05/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Malarial Fever by Unani medicine Malerian |
|
Scientific Title of Study
|
Clinical Validation of Unani Pharmacopoeial Formulation Malerian in ḤummÄ AjÄmiyya (Malarial Fever) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HA/MF/M/CLNVAL/CCRUM /18-19, Version 1, 10-04-19 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Asim Ali Khan |
| Designation |
Director General |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
01128525715 |
| Fax |
|
| Email |
unanimedicine@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naheed Parveen |
| Designation |
Assistant Director |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
9213511298 |
| Fax |
|
| Email |
ccrum507@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Kumar |
| Designation |
Research Officer (Pathology) S-IV |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
8800263300 |
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support : 1 Regional Research Institute of Unani Medicine (RRIUM), Aligarh Monetary Support : Central Council for Research in Unani Medicine (CCRUM), New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine CCRUM New Delhi |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058. |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Misbahuddin Azhar |
Regional Research Institute of Unani Medicine (RRIUM) |
Post Box 70, Shahjahan Manzil, Near AMU Riding Club, Qila Road, Research OPD Room (Malarial Fever)
Aligarh
UTTAR PRADESH |
8802140093
misbahuddindr1980@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Regional Research Institute of Unani Medicine, Aligarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B529||Plasmodium malariae malaria without complication, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Malerian |
6ml orally twice daily with water for 2 weeks |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex of age 18-65 years.
2. 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.
3. Mono-infection with P. vivax confirmed by either positive blood smear (i.e. no mixed
infection) or RDT (Rapid Diagnostic Test). |
|
| ExclusionCriteria |
| Details |
1. 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. (acc. to WHO definition)
2. Mixed or mono-infection with Plasmodium species other than P. vivax detected by
microscopy.
3. Patients associated with other known conditions requiring long term treatment like TB,
AIDS, diabetes, hypertension etc.
4. Reported allergy to any antimalarial drugs, including sulfa and artemisinin drugs.
5. Patients with Glucose-6-phosphate dehydrogenase deficiency
6. Pregnant and lactating females. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in signs and symptoms of ḤummÄ AjÄmiyya (Malarial Fever) |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical assessment for safety assessment |
Investigations will be done at baseline and end of treatment |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
21/05/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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
|
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
|
|