| CTRI Number |
CTRI/2021/09/036364 [Registered on: 09/09/2021] Trial Registered Prospectively |
| Last Modified On: |
09/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To assess the effect of Ayurvedic medicines on gout |
|
Scientific Title of Study
|
Clinical Evaluation of Gokshuradi Guggulu and Nimbadi Churna in Vatarakta (Gout) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Poonam Mohod |
| Designation |
Research Officer ( Ayurveda) |
| Affiliation |
Regional Ayurveda Research Institute (RARI) |
| Address |
Regional Ayurveda Research Institute (RARI)
Rajinder Nagar Bantalab Jammu
Regional Ayurveda Research Institute (RARI)
Rajinder Nagar Bantalab Jammu
Jammu
JAMMU & KASHMIR
181123
India |
| Phone |
8511437041 |
| Fax |
01912546475 |
| Email |
poonarnawa@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonam Mohod |
| Designation |
Research Officer ( Ayurveda) |
| Affiliation |
Regional Ayurveda Research Institute (RARI) |
| Address |
Regional Ayurveda Research Institute (RARI)
Rajinder Nagar Bantalab Jammu
Regional Ayurveda Research Institute (RARI)
Rajinder Nagar Bantalab Jammu
Jammu
JAMMU & KASHMIR
181123
India |
| Phone |
8511437041 |
| Fax |
01912546475 |
| Email |
poonarnawa@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Poonam Mohod |
| Designation |
Research Officer ( Ayurveda) |
| Affiliation |
Regional Ayurveda Research Institute (RARI) |
| Address |
Regional Ayurveda Research Institute (RARI)
Rajinder Nagar Bantalab Jammu
Regional Ayurveda Research Institute (RARI)
Rajinder Nagar Bantalab Jammu
Jammu
JAMMU & KASHMIR
181123
India |
| Phone |
8511437041 |
| Fax |
01912546475 |
| Email |
poonarnawa@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurvedic Sciences |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Ayurvedic Sciences CCRAS |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan
61-65 Institutional Area, Opposite 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 Dipsundar Sahu |
Central Ayurveda Research Institute |
4 CN Block Sector-V, Salt Lake, Kolkata 700091
Kolkata
WEST BENGAL |
8895173999
drdssahu@gmail.com |
| Dr Poonam Mohod |
Regional Ayurveda Research Institute |
Rajinder Nagar, Bantalab, Jammu
Jammu
JAMMU & KASHMIR |
8511437041
poonarnawa10@gmail.com |
| Dr S B Singh |
Regional Ayurveda Research Institute |
Aamkho, Gwalior
Gwalior
MADHYA PRADESH |
9782560296
dr.shyam84@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Central Ayurveda Research Institute Kolkata |
Approved |
| Regional Ayurveda Research Institute Gwalior |
Approved |
| Regional Ayurveda Research Institute Jammu |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M190||Primary osteoarthritis of other joints. Ayurveda Condition: Vataraktam, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gokshuradi Guggulu , Reference: AFI, Part-I, 5:3 and API , Part-II, Vol. II, Pg 112, Route: Oral, Dosage Form: Guggulu , Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: (2) Medicine Name: , Reference: Nimbadi Churna , Route: AFI, Part-I, 7:20 and API Part II Vol I, Pg 52, Dosage Form: Guggulu , Dose: 9(3), Frequency: g, Bhaishajya Kal: bd, Duration: Adhobhakta, anupAna/sahapAna: No, Additional Information: -lukewarm water |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex aged between 25 and 65 years
Confirmed cases of Primary Gouty arthritis fulfilling the diagnostic criteria as recommended by the American College of Rheumatology (1977), it should meet the presence of any six of the following twelve criteria:
More than one attack of acute arthritis.
Maximal Inflammation developing within 1 day of onset.
Monoarthritis attack
Redness over affected joint
Unilateral attack on the first Metatarsophalangeal (Big Toe) joint.
Unilateral attack involving Tarsal joint.
First Metatarsophalangeal (Big Toe) joint Painful or Swollen.
Suspected Tophi
Hyperuricemia (≥7.0 mg/dl)
Asymmetrical swelling within joint (X Ray)
Sub cortical cysts without erosions(X Ray)
Negative culture from joint fluid during attack.
Willing and able to participate in the study for 14 weeks.
|
|
| ExclusionCriteria |
| Details |
Age less than 25 yrs or more than 65yrs.
ii. History of any trauma/ fractured joint/ surgical/diagnostic intervention with reference to the affected joint(s).
iii. Patients with co-morbidities such as Rheumatoid arthritis, Psoriatic arthritis etc.
iv. Patients with poorly controlled Hypertension (>160/100 mm of Hg).
v. Patients with poorly controlled Diabetes Mellitus (HbA1c > 8.0%)
vi. Patients with evidence of malignancy.
vii. Patients with unstable cardio-vascular disease.
viii. Known cases of Hypothyroidism or hyperthyroidism.
ix. Patients with any concurrent hepatic disorder or Renal Disorders (S. Creatinine >1.2 mg/dl) or Severe COPD.
x. Alcoholics/drug abusers.
xi. H/o hypersensitivity to any of the trial drugs or their ingredients.
xii. Pregnant/lactating woman.
xiii. Any other condition which the Principal Investigator thinks may jeopardize the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in Pain assessment on VAS scale
Change in Ayurvedic parameters of Vatarakta
|
3 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean percentage decrease in Serum Uric Acid levels from the baseline to the end of study period.
Improvement in SF-36 Health Survey score
Change in Physician’s Global Assessment.
|
2 years |
|
|
Target Sample Size
|
Total Sample Size="165"
Sample Size from India="165"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
15/09/2021 |
| 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
|
The trial results would be published by Central Council for Research in Ayurvedic Sciences at the end of clinical trial |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Vatarakta is the major example of vata vyadhi, caused due to Avarana pathology. It is a disease which is associated with an inheretent abnormality of purine metabolism resulting in over production of uric acid. It is characterized by acute attack pain and swelling of one or more joints. In untreated cases uric acid in the form of monosodium urate gets deposited in the cartilage of joints and later on it causes deformities. The literature enlists a number of Guggulu prayogas in the management of vatarakta. An additional cavernous revise was indispensable to bring out the precise outcome of these products.Keeping these visions in mind, the particular comparative study was performed with Gokshuradi Guggulu and Nimbadi Churna which are explained in the same context, Aim and object of this study is to evaluate their therapeutic efficacy in the patients of Vatarakta ( Gout) along with safety measures by observing adverse events ( AE) if any or Adverse drug reaction ( ADR). The efficacy of these drugs would be assessed by observing the improvement in Subjective parameters ( Clinical symptoms), mean percentage decrease in serum uric acid levels, improvement in SF-36 Health survey score, patients global assessment, physicians global assessment, pain VAS scale and lab parameters. |