| CTRI Number |
CTRI/2024/08/072000 [Registered on: 06/08/2024] Trial Registered Prospectively |
| Last Modified On: |
23/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study on Gout to evaluate the safety and efficacy of Polyherbal formultion. |
|
Scientific Title of Study
|
A single blind observational study to evaluate the safety and efficacy of polyherbal formulation in the management of Niqris (Gout). |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tabasum Fatima |
| Designation |
Research Associate |
| Affiliation |
Islamic University of Science and Technology |
| Address |
Islamic University of Science and Technology, Awantipora, Pulwama.Department: Centre for AYUSH Sciences, Ayush health and wellness centre, OPD no:1
Pulwama JAMMU & KASHMIR 192122 India |
| Phone |
9419421375 |
| Fax |
|
| Email |
tabasumfatima281@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Tabasum Fatima |
| Designation |
Research Associate |
| Affiliation |
Islamic University of Science and Technology |
| Address |
Islamic University of Science and Technology, Awantipora, Pulwama.Department: Centre for AYUSH Sciences, Ayush health and wellness centre, OPD no:1
JAMMU & KASHMIR 192122 India |
| Phone |
9419421375 |
| Fax |
|
| Email |
tabasumfatima281@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Tabasum Fatima |
| Designation |
Research Associate |
| Affiliation |
Islamic University of Science and Technology |
| Address |
Islamic University of Science and Technology, Awantipora, Pulwama.Department: Centre for AYUSH Sciences, Ayush health and wellness centre, OPD no:1
JAMMU & KASHMIR 192122 India |
| Phone |
9419421375 |
| Fax |
|
| Email |
tabasumfatima281@gmail.com |
|
|
Source of Monetary or Material Support
|
| Islamic University of Science and Technology |
|
|
Primary Sponsor
|
| Name |
Islamic University of Science and Technology |
| Address |
Islamic University of Science and Technology. Awantipora, Pulwama, 192212 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Tabasum Fatima |
AYUSH Health and Wellness Centre |
Islamic University of Science and Technology.Department: Centre for AYUSH Sciences, Ayush healyh and wellness centre, OPD no:1 Pulwama JAMMU & KASHMIR |
9419421375
tabasumfatima281@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Islamic University of Science and technology |
Approved |
|
|
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 |
| Intervention |
Drugs namely Suranjan (ColchicumLuteum), Khulanjan (Alpinia Galanga) and Bozidan (Pyrethrum Indicum) |
The drugs will be ground into fine powder then 5 grams of the drug will be given three times a day orally for 60 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of either sex will be selected for the study.
2.Between 18 to 60 years of age.
3.Fulfilling the criteria of American College of Rheumatology for diagnosing Gouty Arthritis including clinical features, laboratory, and radiological finding will be included in the study, who had serum Uric Acid level more than 7mg/dl.
|
|
| ExclusionCriteria |
| Details |
1.Patients below 18 and above 60 years of age.
2.Pregnant and Lactating mothers.
3.Patients who fail to give consent.
4.Patients of Gout associated with any systemic disorder which interfere with patient study will be excluded.
5.Patients of Gout associated with any severe Arthritis condition. Such as Rheumatoid arthritis, Septic arthritis will be excluded from the study
6.Patients suffering from Anemia and other blood dyscrasias like leukemia, hemophilia etc
7.Patients with history of suffering with congenital Gout.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Serum uric acid level.
2. CRP
3. ESR
|
2 years
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Pain Tenderness and Swelling in the affected joints
2 Difficulty in movement.
3 Affected joint redness (Erythema).
|
2 years |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/08/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 16-06-2026 and end date provided 15-06-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Niqris (Gout) is one of the most common types
of inflammatory jointdiseases creating difficulty and problems in day to day
life. Itis characterized by recurrent attacks of acute pain and swelling
primarily affecting one joint usually the metatarso-phalangeal joint of big toe
and small joints of feet and hands, commonly affects both feet.The
prevalence of Gout varies between population but is approximately 1-2%
and out of the affected population males are more common while females of the
postmenopausal group are at high risk. According to Hippocrates, it
occurs rarely in children and premenopausal women and does not occur in
transgenders. Six centuries later to Buqrat, Jalinoos was the first to describe tophi. An excessive
intake of food containing high purine contents (Baadi Ghiza) is the primary or essential cause of Gouty Arthritis (Niqris), which results in deposition of Maddah-e-Niqris (urates or tophi), in
the articular and periarticular tissues.In modern medicine NSAID’s, Uricosuric
drugs, colchicine, glucocorticoids etc. are used for subsiding acute attacks or
lowering serum uric acid which is associated with potent adverse effects like
vomiting, GI bleeding, hepato-renal toxicity, hypersensitivity etc.
The side effects of all above-mentioned drugs call for the development of novel
drugs or methods of treatment used with similar and better efficacy and lesser
toxicity than presently available drugs.Now a days Unani system of Medicine is
getting authentication for the treatment of such type of disease by its unique
concept which is equilibrium of humors, for this purpose different methods of
treatment are applied like Ilaj bil Giza (Dietotherapy), Ilaj bil Dawa
(Pharmacotherapy) , Ilaj bil Tadbeer (Rehimenal Therapy), and Ilaj bil Yad
(Surgery). The Unani medicines being having less side effects are more beneficial,
thus the present study has been designed to study the efficacy and safety of
the poly herbal formulation, constituting the drugs namely Suranjan (ColchicumLuteum),
Khulanjan (Alpinia Galanga) and Bozidan
(Pyrethrum Indicum)
Diagnostic Criteria: Patients with classical sign and symptom of Niqris (Gout) with uric acid level more
than 7mg/dl.
Study design: Single blind,
observational study.Sample size: 30 patients
Intervention.
Test group: Powder of Suranjan, Khulanjan and Bozidan.
Method of
Prepration: The drugs will be grinded into fine powder and all will be mixed
properly.
Dosage: 5 gm of each drug ie a total of 15grams of drug will be given in
three divided doses every day.
Route of Administration:Oral
Duration of Protocol: 60 days with
follow up as ( 15th, 30th,45th,60th)
Duration of Study: 2 years
Procedure of study:
Enrolled cases
of Gout will be recruited after obtaining a written informed consent.
The pre and post treatment subjective and objective findings
(effects) will be compared and its significance will be evaluated through a
suitable statistical test.
|