| CTRI Number |
CTRI/2015/03/005610 [Registered on: 05/03/2015] 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 two Unani formulations in the treatment of Gout |
|
Scientific Title of Study
|
Clinical Validation of Unani Pharmacopoeial Formulations - MÄjÅ«n-e-SÅ«ranjÄn & Habb-e-AzÄrÄqi in Niqris (Gout) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| N/G/MSHA CLNVAL/CCRUM 13-14 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PROF S SHAKIR JAMIL |
| 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
West
DELHI
110058
India |
| Phone |
|
| Fax |
01128522965 |
| Email |
unanimedicine@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR K M SIDDIQUI |
| Designation |
DEPUTY 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
West
DELHI
110058
India |
| Phone |
9810161758 |
| Fax |
01128522965 |
| Email |
ccrum507@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PRADEEP KUMAR |
| Designation |
RESEARCH OFFICER SCIENTIST III |
| 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
West
DELHI
110058
India |
| Phone |
|
| Fax |
01128522965 |
| Email |
drpradeepkumar2001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support: 1.Central Research Institute of Unani Medicine (CRIUM), Lucknow 2.Regional Research Institute of Unani Medicine (RRIUM),Chennai 3.Regional Research Institute of Unani Medicine (RRIUM),Aligarh 4.Clinical Research Unit (CRU),Buhranpur
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 = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SHAMSUL ARFIN |
Central Research Institute of Unani Medicine (CRIUM), Lucknow |
C-39, Jankipuram,P.O., Sector-C ,Terhi Puliya, Kursi Road
Lucknow
UTTAR PRADESH |
05222361720
05222732088
crium_lko@yahoo.co.in |
| DR MUJAHID SAMI |
Clinical Research Unit (CRU), Bhurhanpur |
Ganpati Naka Burhanp
West Nimar
MADHYA PRADESH |
09827541428
mahajankk@rediffmail.com |
| DR RIFAT M AFRIDI |
Regional Research Institute of Unani Medicine (RRIUM), Aligarh |
Post Box 70, Near Head Post Office
Aligarh
UTTAR PRADESH |
05712704781
rrium_aligarh@rediffmail.com |
| DR K KABIRUDDIN AHMAD |
REGIONAL RESEARCH INSTITUTE OF UNANI MEDICINE, Chennai |
No.1, West Madha Church Road, Royapuram
Chennai
TAMIL NADU |
04425955532
rriumchennai@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Central Research Institute of Unani Medicine (CRIUM), Lucknow |
Approved |
| Clinical Research Unit (CRU), Bhurhanpur |
Approved |
| Regional Research Institute of Unani Medicine (RRIUM), Aligarh |
Approved |
| REGIONAL RESEARCH INSTITUTE OF UNANI MEDICINE, Chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M109||Gout, unspecified, Niqris (Gout) , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1.Majoon-e-SÅ«ranjÄn
2.Habb-e-Azaraqi |
1.Majoon SÅ«ranjÄn, 5gm.Orally,twice daily with water after meals
2.Habb-e-Azaraqi, Orally, 1 pill twice daily with water after meals
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
• Patients of either sex in the age group of 18-60.
• Serum uric acid level: normal or above normal
• Patients of gout having any of the following symptoms and signs:
 Joint Pain (especially first metatarsophalangeal (MTP) joint)
 Tenderness
 Swelling
 Redness
|
|
| ExclusionCriteria |
| Details |
• Other diseases involving small & large joints
• Pregnant and lactating women
• Patients having any systemic diseases such as hypertension, diabetes mellitus, Cardiovascular/Cerebrovascular diseases, hepatic and renal disease, osteomalacia, osteoporosis
• Obesity (BMI: ≥ 30)
• Patients on long term medications
• Patients taking drugs which increase serum uric acid levels (thiazide diuretics, etc.) and decrease serum calcium levels (furosemide, etc.)
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in signs and symptoms of Niqris (Gout) |
Improvement in signs and symptoms of Niqris (Gout) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical assessment for safety assessment |
12 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)
|
01/05/2014 |
| 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 Niqris (Gout). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically every two weeks. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 8 weeks. . Laboratory parameters for safety assessment will be conducted at baseline, first follow up and end of study.
Composition
I. MÄjÅ«n-e-SÅ«ranjÄn
Name
of Ingredients Botanical Name Quantity Actions
1.
Suranjan Shireen (Merendera persica) 500 gm Mudir-e-Bawl,
Mohallil
2. Sana (Cassia angustifolia) 250 gm
Qabiz
3. Zanjabeel (Zingiber officinale) 100 gm Mushtahi,
Hazim, Kasir-e-Riyah
4. Zeera Siyah (Carum carvi) 100 gm Hazim,
Kasir-e-Riyah, Mudir-e-
Haiz,
Ahtbas-e-Haiz
5. Filfil Daraz (Piper longum) 100 gm Sual,
Dama, Kali Khansi
6. Asaroon (Asarum europaeum) 100 gm Sara, Laqwa,
Falij
7. Asl Or Qand Safaid 3.5
kg
II. Habb-e-AzÄrÄqi
1. Azaraqi Mudabbar (Strychnos
nux-vomica) 20 gm Falij, Laqwa
2. Filfil Siyah (Piper nigrum) 10 gm Zof-e-Qalb, Mushtahi
3. Filfil Daraz (Piper longum) 10 gm Sual, Dama, Kali Khansi
4. Arq-e-Ajwayin (Ptycotis ajowan) Q. S. Hazim, Kasir-e-Riyah
|