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CTRI Number  CTRI/2019/03/018087 [Registered on: 14/03/2019] Trial Registered Prospectively
Last Modified On: 12/03/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Single Arm Study 
Public Title of Study   Treatment of Skin eruptions by Unani medicine Habb e Musaffi Khoon 
Scientific Title of Study   Clinical Validation of Unani Pharmacopoeial Formulation Hab-e-Musaffi Khoon in Busoor-e-Jild (Skin Eruptions) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
BJ/SE/HMK/CLNVAL/CCRUM/17-18, version 1  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), Bhadrak 2. Regional Research Institute of Unani Medicine (RRIUM), New Delhi 3. Regional Research Centre (RRC), Silchar 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  
Name  Address 
Nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Akhter Hussain Jamali  Regional Research Institute of Unani Medicine (RRIUM)  S M Dev Civil Hospital, Silchar
Cachar
ASSAM 		 8811907160

crukxj522@gmail.com 
Dr Rahat Raza  Regional Research Institute of Unani Medicine (RRIUM)  D 11, Abul Fazal Enclave, Jamia Nagar
South
DELHI 		 9911315309

rridelhi@gmail.com 
Dr Syed Abdullah Hussaini  Regional Research Institute of Unani Medicine (RRIUM)  Chandbali By pass Road, Near Rural Police Station
Bhadrak
ORISSA 		 06784251289

rriumbdk_unani@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Regional Research Centre, Silchar  Submittted/Under Review 
Regional Research Institute of Unani Medicine, Bhadrak  Submittted/Under Review 
Regional Research Institute of Unani Medicine, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R21||Rash and other nonspecific skin eruption,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hab-e-Musaffi Khoon   Oral Adult: 4 pills (each 80mg) Daily To be taken with water for two weeks 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  The following criteria will be strictly followed for inclusion of cases in an observational study.
1. Patients of either sex in the age group of 15 to 60 years.
2. Occurrence of the following (5-15 in number):
i. Vesicles (a vesicle is a small blister, as on the skin. Vesicles are less than 0.5 centimeters in diameter)
ii. Papules (Small solid rounded bumps rising from the skin that are each usually less than 1 centimeter in diameter (less than 3/8 inch across)
iii. Pustules (Small solid rounded bumps rising from the skin that are each usually less than 1 centimeter in diameter (less than 3/8 inch across)
iv. Macules (Flat , distinct, colored area of the skin less than 1 cm in diameter)
 
 
ExclusionCriteria 
Details  The patients of Busoor-e-Jild (Skin Eruptions) with following conditions will be excluded from the study:
1. Age <15 years and >60 years
2. Pregnancy and Lactation
3. Patients with disorders requiring long term treatment
4. Patients with more than 15 skin eruptions
5. Size of skin eruption more than 1cm
6. Eruptions due to viral diseases (Chicken pox, Measles, Herpes)
7. Patients with other inflammatory skin conditions like localized abscess/ carbuncles/ boils. 
 
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 Busoor-e-Jild (Skin Eruptions)  Two 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="240"
Sample Size from India="240" 
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)   18/03/2019 
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 Busoor-e-Jild (Skin Eruptions). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be treated with Unani pharmacopoeial formulation Hab-e-Musaffi
 Khoon four pills daily with water for two weeks.  The patients will be assessed at every week. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be two weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.

Composition of Hab-e-Musaffi Khoon

S. No.

Ingredients

Botanical/Scientific name

Quantity
  1.  

Berg Bakayin

Melia azedarach Linn.

10 gm.
  1.  

Berg Neem

Azadirachta indica A. Juss.

10 gm.
  1.  

Berg Hina

Lawsonia alba

30 gm.
  1.  

Burada Sandal Surkh

Pterocarpus santalinus Linn. f.

30 gm.
  1.  

Barhamdandi

Tricholepis glaberrima DC.

30 gm.
  1.  

Post Haleela Zard

Terminalia chebula Retz.

30 gm.
  1.  

Chaksu

Cassia absus Linn.

30 gm.
  1.  

Rasaut (extract)

Berberis aristata DC.

30 gm.
  1.  

Zeera Safaid

Cuminum cyminum Linn.

10 gm.
  1.  

Sarphoka

Tephrosia purpurea (L.) Pers.

30 gm.
  1.  

Shahtra

Fumaria officinalis Linn.

30 gm.
  1.  

Filfil Siyah

Piper nigrum Linn.

10 gm.
  1.  

Kishneez Khushk

Coriandrum sativum Linn.

30 gm.
  1.  

Post Kachnal

Bauhinia variegata Linn.

10 gm.
  1.  

Gul-e-Surkh

Rosa damascena Mill.

30 gm.
  1.  

Neelkanthi

Ajuga bracteosa Wall. ex Benth.

30 gm.

 
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