| CTRI Number |
CTRI/2019/02/017821 [Registered on: 26/02/2019] Trial Registered Prospectively |
| Last Modified On: |
26/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Gout with Unani medicine Safoof Chobchini |
|
Scientific Title of Study
|
Clinical Validation of Unani Pharmacopoeial Formulation Safoof Chobchini in Niqris (Gout) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| N/G/SC/CLNVAL/CCRUM /17-18/, Version 1, Date 23.07.18 |
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 |
| 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 (Unani) |
| Affiliation |
Central Council for Research in Unani Medicine |
| 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 (Path) SIV |
| Affiliation |
Central Council for Research in Unani Medicine |
| 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), Mumbai 2. Regional Research Institute of Unani Medicine (RRIUM), Patna 3. Regional Research Centre (RRC), Allahabad Monetary Support : Central Council for Research in Unani Medicine (CCRUM), New Delhi |
|
|
Primary Sponsor
|
| Name |
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-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 Ashok Kumar |
Regional Research Centre (RRC) |
B 501/4,G T B Nagar, Opp Dulhan Palace
Allahabad
UTTAR PRADESH |
9450619024
drashokkumarrrc@gmail.com |
| Dr Irfan Ahmad |
Regional Research Institute of Unani Medicine (RRIUM) |
Behind Eye Bank, Sir J J Hospital Compound, Byculla
Mumbai
MAHARASHTRA |
02223742173
rrium.mumbai@gmail.com |
| Dr Mumtaz Ahmad |
Regional Research Institute of Unani Medicine (RRIUM) |
Guzri, Patna City
Patna
BIHAR |
9140843920
mumtazahmad1966@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Regional Research Centre, Allahabad |
Submittted/Under Review |
| Regional Research Institute of Unani Medicine, Mumbai |
Approved |
| Regional Research Institute of Unani Medicine, Patna |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M109||Gout, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
Safoof Chobchini |
5 gm Orally Twice daily with water after meals |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
(All of the following)
1. Patients of either sex in the age group of 18-65 years
2. Serum uric acid level: normal or above normal
3. Diagnosed cases of gout as per the ACR/ EULAR-2015 criteria for gout presenting with any of the following symptoms and signs:
4. Joint Pain [especially first metatarsophalangeal (MTP) joint]
5. Tenderness
6. Swelling
7. Redness |
|
| ExclusionCriteria |
| Details |
(Any of the following)
1. Clinical conditions involving joints e.g. Osteo-arthritis, Rheumatoid arthritis, Rheumatic arthritis
2. Pregnant and lactating women
3. Patients having any systemic diseases such as hypertension, diabetes mellitus, cardiovascular/cerebrovascular diseases, hepatic and renal disease, osteomalacia, osteoporosis
4. Patients with recent H/O dengue, chikungunya and viral fever
5. Grade-2 obesity (BMI ≥ 35)
6. Patients on long term medications
7. Patients taking drugs which increase serum uric acid levels (thiazide diuretics, etc.) and decrease serum calcium levels (furosemide, etc.) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in sign and symptoms of Niqris (Gout) |
6 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)
|
08/03/2019 |
| 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 Niqris (Gout). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at every 2 weeks. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be six weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy. Composition of Safoof-e-Chobchini | S.No. | Ingredients | Botanical/Scientific name46 | Quantity | | 1. | Chobchini | Smilax china | 40 gm. | | 2. | Sana | Cassia angustifolia | 25 gm. | | 3. | Ushba Maghribi | Smilax aristolochiaefolia | 20 gm. | | 4. | Bisfaayej | Polypodium vulgare | 20 gm. | | 5. | Suranjan | Colchicum luteum | 10 gm. | | 6. | Aftimoon | Cuscuta reflexa | 10 gm. | | 7. | Gul-e-Surkh | Rosa damascena | 10 gm. | | 8. | Sandal Safaid | Santalum album | 10 gm. | |