| CTRI Number |
CTRI/2014/01/004283 [Registered on: 06/01/2014] Trial Registered Retrospectively |
| Last Modified On: |
03/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the Safety and efficacy of Unani formulations in the treatment of (Pustules/Boils) |
|
Scientific Title of Study
|
Validation of Unani Pharmacopoeial formulations in Busoor-e-Jild (Pustules/Boils) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abdul Hannan |
| Designation |
Joint Director |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM), |
| Address |
Central Council for Research in Unani Medicine (CCRUM), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi
Central Council for Research in Unani Medicine (CCRUM), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi
South
DELHI
110058
India |
| Phone |
01128521981 |
| Fax |
01128522965 |
| Email |
ccrum605@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abdul Hannan |
| Designation |
Joint Director |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM), |
| Address |
Central Council for Research in Unani Medicine (CCRUM), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi
Central Council for Research in Unani Medicine (CCRUM), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi
DELHI
110058
India |
| Phone |
01128521981 |
| Fax |
01128522965 |
| Email |
ccrum605@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abdul Hannan |
| Designation |
Joint Director |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM), |
| Address |
Central Council for Research in Unani Medicine (CCRUM), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi
Central Council for Research in Unani Medicine (CCRUM), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi
DELHI
110058
India |
| Phone |
01128521981 |
| Fax |
01128522965 |
| Email |
ccrum605@gmail.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support :
1. Regional Research Institute of Unani Medicine(RRIUM), BHADRAK
2. Regional Research Centre, Allahabad
3. Clinical Research Unit, Burhanpur
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 |
Central Council for Research in Unani Medicine (CCRUM), 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 = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mujahid Sami |
Clinical Research Unit, Burhanpur |
Ganpati Naka Burhanpur
West Nimar
MADHYA PRADESH |
09827541428
mahajankk@rediffmail.com |
| Dr Zubair Ahmad Khan |
Regional Research Centre Allahabad |
B- 501/4, G.T.B. Nagar ( Opp. Dulhan Place) Allahabad
Allahabad
UTTAR PRADESH |
05322551808
05322655105
rrcallahabad@gmail.com |
| DR MAHE ALAM |
Regional Research Institute of Unani Medicine, Bhadrak |
Motel Chhak, Mathasahi, Bhadrak-756100 (Odisha)
Bhadrak
ORISSA |
06784240289
06784240289
mahealam_234@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| CRU, Burhanpur, Institutional Ethics Committee, Burhanpur, M.P. Dr. Mujahid Sami, Principal Investigator |
Approved |
| RRC, Allahabad, Institutional Ethics Committee, Allahabad U.P., Dr. Zubair Ahmad Khan, Principal Investigator |
Approved |
| RRIUM Bhadrak Institutional Ethics Committee, Bhadrak, Dr. Mahe Alam, Principal Investigator |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Busoor-e-Jild (Pustules/Boils) , (1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1. Majoon-e-Ushba
2.Arq Murakkab Musaffi
Khoon
|
1. Majoon-e-Ushba - 12gm orally daily
2.Arq Murakkab Musaffi
Khoon - 25 ml orlly twice daily
Both the agents are being given to the same patient
Duration of therapy : 06 weeks
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex in the age group of 5 to 60 years.
2. Frequent occurrence of the following
3. Vesicles (a vesicle is a small blister, as on the skin. Vesicles are less than .5 centimeters in diameter)
4. 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)
5. 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)
6. Macules (Flat , distinct, colored area of the skin less than 1 cm in diameter)
|
|
| ExclusionCriteria |
| Details |
1. Age 5 years and 60 years
2. Patients with diseases/ disorders requiring long term treatment
3. Patients with Diabetes mellitus
4. Patients with other inflammatory skin conditions like localized abscess/ carbuncles/ boils.
5. Pregnancy and Lactation |
|
|
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 |
6 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hematological and biochemical assessments for safety |
6 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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 2 |
|
Date of First Enrollment (India)
|
02/11/2011 |
| 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) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
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 (Pustules/Boils) After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The clinical follow-up will be carried out weekly for the 1st month and every 2 weeks for the rest of the study.This includes subjective assessment of general well being and physical examination. The total duration of treatment will be 06 weeks. . Laboratory parameters for safety assessment will be conducted at baseline and end of study.
Composition of Majoon-e-Usba
1.
Sana 80
g
2.
Sandal Surakh 60 gm.
3.
Sandal Safaid 60 gm.
4.
Chobchini 60 gm.
5.
Gul-e-Surkh 60 gm.
6.
Darchini 40 gm.
7.
Kababchini 40 gm.
8.
Gaozaban 40 gm.
9.
Atimoon 40 gm.
10.
Bisfayaj 40 gm.
11.
Post-e-Balela 20 gm.
12.
Sumbul-ut-Teeb 20 gm.
13.
Halela Siyah 15 gm.
14.
Post-e-Halela
Zard 10 gm.
15.
Asal OR Qand
Safaid 2 kg.
Sharbat Murakkab Musaffi Khoon
1. Burada Aabnoos 50
g.
2. Burada Sheesham 50
g.
3. Burada Sandal Surkh 100
g.
4. Burada Sandal Safaid
50g.
5. Barg e Hina 50g
6. Barg e Neem 250g
7. Brahm dandi
50g
8. Post Halela Zard
50g.
9. Chiraita talkh 50
g.
10.
Sarphoka 50 g. 50g
11.
Shahtara 100 g 50g
12.
Unnab 250
g.
13.
Gul Mundi 50g
14.
Gul Neelofer 50g
15.
Neel Kanthi 50g
16.
Halela Siyah neem Kofta 50g
17.
Water
5ltrs
|