CTRI

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CTRI Number

CTRI/2023/07/055000 [Registered on: 10/07/2023] Trial Registered Prospectively

Last Modified On:

07/07/2023

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Randomized, Parallel Group Trial

Public Title of Study

To compare efficacy of kokilakshadi kashayam & kaishore gugguluin management of vatarakra wsr to gout

Scientific Title of Study

A comparative study to evaluate the efficacy of kokilakshadi kashayam & kaishore guggulu in management of vatarakta wsr to 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	Anjali Jamra
Designation	PG Scholar
Affiliation	Shri Krishna government ayurvedic college and hospital
Address	Room No 56 Department of Kaya Chikitsa Shri krishna government ayurvedic college and hospital, Sec 8,Umri road ,Kurukshetra Kurukshetra HARYANA 136118 India
Phone	8234040010
Fax
Email	pinkyjamra27@gmail.com

Details of Contact Person
Scientific Query

Name	Neha Lamba
Designation	Assistant Professor Department of Kaya Chikitsa
Affiliation	Shri Krishna government ayurvedic college and hospital
Address	Room No 56 Department of Kaya Chikitsa Shri krishna government ayurvedic college and hospital, Sec 8,Umri road ,Kurukshetra Kurukshetra HARYANA 136118 India
Phone	9736333868
Fax
Email	drlamba.neha@gmail.com

Details of Contact Person
Public Query

Name	Anjali Jamra
Designation	PG Scholar
Affiliation	Shri Krishna government ayurvedic college and hospital
Address	Room No 56 Department of Kaya Chikitsa Shri krishna government ayurvedic college and hospital, Sec 8,Umri road ,Kurukshetra HARYANA 136118 India
Phone	8234040010
Fax
Email	pinkyjamra27@gmail.com

Source of Monetary or Material Support

Shri Krishna government ayurvedic college and hospital, Sec 8 ,Umri Road , kurukshetra

Primary Sponsor

Name	Shri krishna government ayurvedic college and hospital sec 8 umri road kurukshetra
Address	Shri krishna government ayurvedic college and hospital, Sec 8,Umri road ,Kurukshetra
Type of Sponsor	Government medical college

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Anjali Jamra	Shri Krishna Government Ayurvedic hospital	Room No 56 Department of Kaya Chikitsa Kurukshetra HARYANA	08234040010 pinkyjamra27@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee Shri Krishna Ayush University Kurukshetra	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:E790\|\|Hyperuricemia without signs of inflammatory arthritis and tophaceous disease. Ayurveda Condition: VATARAKTAM,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: Kokilakshadi Kashayam, Reference: Bhaishajya Ratnavali Vatarakta Chikitsa, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -Kokilakshadi Kashayam will be given with Prakshep of 3 gram Pippali Churna
2	Comparator Arm	Drug	Classical		(1) Medicine Name: Kaishore Guggulu, Reference: Bhaishajya Ratnavali Vatarakta Chikitsa, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -

Inclusion Criteria

Age From	19.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1.Patients between the age group of 19-60 years of either sex presented with clinical features of VataRakta/ Gout. 2.Diagnosed and confirmed the case of VataRakta (Gout). 3.Patients have serum uric acid levels of more than 6mg/dl in females & more than 7mg/dl in males with or without any associated features like joint pain and inflammation.

ExclusionCriteria

Details

1.Patients below 19 years and above 60 years will be excluded
2.Patients suffering from other forms of Arthritis like Rheumatoid arthritis, Osteoarthritis, Ankylosing spondylitis, Infective arthritis, etc.
3.Pregnant and lactating mother.
4.Subject showing the uric acid level above 9mg/dl.
5.Patients with evidence of malignancy & on chemotherapy drugs.
6.Patients having any disorders like Diabetes mellitus, Cardiac disease, CRF, ARF, etc.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Other

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
The efficacy of Kokilakshadi Kashayam and Kaishore Guggulu will be noted in respective groups as per changes in subjective criteria on the 15th 30th day and 60th-day post-treatment and repeat lab investigation (CBC, ESR, CRP (Quantitative), Serum UA, Blood Urea, Serum Creatinine, RA Factor) will be done post-treatment.	30 days of treatment with follow up on 15th, 30th and 60th day

Secondary Outcome

Outcome	TimePoints
1) To Compare efficacy of Kokilakshadi Kashaya & Kaishore Guggulu after complete treatment & follow up of both groups. 2.Evalution of adverse effect of both drug will be done on each patient during & post treatment.	Final result will be checked post treatment of all patients from both groups & will take approx 1 year 2) Adverse effects will be noted on each patient & each follow up till 60th day

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 2/ Phase 3

Date of First Enrollment (India)

31/07/2023

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="10"
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 - NO

Brief Summary

Vatarakta (Gout) is a metabolic disorder, caused by abrupt change in the lifestyle, change in dietary habits. The incidence of gout varies in population from 0.2 to 3.5 per 1000, with an overall prevalence of 2-26 per 1000. Gout is found to have increased prevalence in recent years. It is rare in children and premenopausal females. The peak age of onset in males is between 40 and 50 years. In modern science, NSAIDs (Non-Steroid Anti Inflammatory Drugs), Xanthine Oxidase Inhibitors (Allopurinol, Febuxostat), Colchicines, Probenecids & corticosteroids are the most widely used medicine for the treatment of Gout, but these have many side effects when used for a longer duration. Keeping in view of the above limitations and side effects, this study has been chosen to fill the gap of providing a safe and effective line of treatment as Ayurveda provides multiple formulations for VataRakta. So, an effort is made to see whether Kokilakshadi Kashayam or Kaishore Guggulu is effective in the management of VataRakta and also comparing their efficacy.In this study, we will have two groups of 30 patients each. these groups will be treated with Kokilakshadi Kashayam and Kaishore Guggulu respectively. We will have a follow up on 0th, 15th and 30th day (During treatment) and on 60th day (post treatment). The changes will be analyze on the basis of subjective and objective parameters in both groups, Then the result will be analyzed by using appropriate statistical method.