| CTRI Number |
CTRI/2023/03/050758 [Registered on: 16/03/2023] Trial Registered Prospectively |
| Last Modified On: |
12/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy and safety of G-Amrita formulation in the management of high uric acid and gouty arthritis |
|
Scientific Title of Study
|
Efficacy and safety of G-Amrita formulation in the management of high uric acid and gouty arthritis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Debasish Hota |
| Designation |
Professor & Head |
| Affiliation |
All India Institute of Medical Sciences Bhubaneswar |
| Address |
Department of Pharmacology
All India Institute of Medical Sciences
Sijua
Bhubaneswar
Khordha ORISSA 751019 India |
| Phone |
9438884190 |
| Fax |
|
| Email |
pharm_debasish@aiimsbhubaneswar.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Debasish Hota |
| Designation |
Professor & Head |
| Affiliation |
All India Institute of Medical Sciences Bhubaneswar |
| Address |
Department of Pharmacology
All India Institute of Medical Sciences
Sijua
Bhubaneswar
Khordha ORISSA 751019 India |
| Phone |
9438884190 |
| Fax |
|
| Email |
pharm_debasish@aiimsbhubaneswar.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Debasish Hota |
| Designation |
Professor & Head |
| Affiliation |
All India Institute of Medical Sciences Bhubaneswar |
| Address |
Department of Pharmacology
All India Institute of Medical Sciences
Sijua
Bhubaneswar
Khordha ORISSA 751019 India |
| Phone |
9438884190 |
| Fax |
|
| Email |
pharm_debasish@aiimsbhubaneswar.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shree Dhanwantri Herbals |
| Address |
Amritsar, Punjab, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ajay Kumar Shukla |
Department of Pharmacology |
All India Institute of Medical Sciences, Bhopal Bhopal MADHYA PRADESH |
09755526266
ajay.pharm@aiimsbhopal.edu.in |
| Prof Debasish Hota |
Department of Pharmacology |
All India Institute of Medical Sciences, Bhubaneswar Khordha ORISSA |
9438884190
pharm_debasish@aiimsbhubaneswar.edu.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS, Bhubaneswar |
Approved |
| Institutional Human Ethics Committee, AIIMS Bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M109||Gout, unspecified. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: G-AMRITA, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 800(mg), Frequency: tds, Bhaishajya Kal: Samudga, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: -), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Allopurinol | 100 mg OD |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
With the data of serum uric acid level more than 8.0 mg/dl |
|
| ExclusionCriteria |
| Details |
1. Significant liver or Renal dysfunction, Hematological disease, Oncological disease, or other life threatens disorders.
2. Condition that need the management of diuretics or analgesics agent
3. Severe cerebrovascular disease or severe heart disease;
4. Mental diseases such as schizophrenia, depressive disorder, and drug dependence
5. Alcohol abuse or dependence
6. Aspartate aminotransferase (GOT) or alanine aminotransferase (GPT) level 2 times higher than the normal upper limit;
7. Creatinine higher than 2 mg/dl
8. Pregnant, lactating, or planning to become pregnant within 3 months; |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • The change in serum mean uric acid after 8 weeks of therapy when compared to baseline |
0, 4 weeks, 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in VAS score
|
0, 4 weeks, 8 weeks |
Change in liver & renal function parameters in blood
|
0, 4 weeks, 8 weeks |
| Changes in hemogram (Hb, TLC, DLC) |
0, 4 weeks, 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
20/03/2023 |
| 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="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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)?
Response - NO
|
|
Brief Summary
|
Many plant extracts and herbs have been used in the treatment and management of Gout and hyperuricemia since long. Out of these plants, Tinospora cordifolia, Terminalia Chebula, Embica officinalis, Terminalia Bellirica and Tribulus terresteris have been chosen to form formulation for Gout and Hyper uricemia. These contains compounds with anti-prolferative, anti-oxidant, anti-inflammatory activities and is known to help in the management of Gout treatment. Tinospora cordifolia is immensely useful due to the presence of different compounds of pharmaceutical significance belonging to various groups such as alkaloids, diterpenoid lactones, glycosides, steroids, sesquiterpenoids, and phenolics. These compounds possess pharmacological properties, which make it anti-diabetic, antipyretic, antiinflammatory, anti-oxidant, hepato-protective, and immuno-modulatory [6]. T. chebula is supposed to have a significant quantity of gallic acid, ellagic acid, tannic acid, β-sitosterol, ethyl gallate, chebulic acid, ascorbic acid, and mannitol, which are responsible for its various pharmacological properties. In one study, it was seen that in addition to possessing superoxide radical scavenging activity (7]. T. bellerica also inhibited uric acid formation, which was indicative of its XO enzyme inhibitory activity. Tribulus terrestris is a natural herb, also known as Puncture vine or Gokhru, used for treating several diseases and found in many tropical and moderate areas of the world, including the US and Mexico, Mediterranean region, and throughout Asia. T. terrestris is aphrodisiac, antihypertensive, diuretic, and antiurolithiatic in nature T. terrestris significantly reduced the excretion of oxalate, calcium, and phosphate along with decreased levels of blood urea nitrogen, uric acid and creatinine in serum. T. terrestris also reduced hyperoxaluria- caused oxidative stress, and restored antioxidant enzyme activity and their expression profile in kidney tissue. Emblica possess a vast ethno medical history and represents a phytochemical reservoir of heuristic medicinal value. It has been suggested in the scientific literature that consumption of it alleviates arthritic pain and Gout. Many pharmacological studies have shown that this plant extracts having antioxidant, anticarcinogenic, antitumor, antigenotoxic, antigout, and anti-inflammatory activities, and supporting its traditional uses. Keeping such benefits in view, it was aimed to study effectiveness and safety profile of G -AMRITA in patients with hyper uricemia and /or Gout |