| CTRI Number |
CTRI/2024/08/072119 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
EFFECT OF ERANDADI GHANAVATI OVER KAISHORA GUGGULU AFTER VIRECHAN IN THE PATIENTS OF VATARAKTA (CHRONIC GOUT) |
|
Scientific Title of Study
|
Effect of Erandadighana vati over Kaishora guggulu after Virechan in the management of Vatarakta(Chronic Gout)- A randomised comparative clinical trial |
| 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 Priya goel |
| Designation |
MD SCHOLAR |
| Affiliation |
ALL INDIA INSTITUTE OF AYURVEDA |
| Address |
618(Seminar Hall) Department Of Kayachikitsa All India Institute Of Ayurveda Gautampuri Sarita Vihar New Delhi
South
DELHI
110076
India |
| Phone |
8076331854 |
| Fax |
|
| Email |
priyagoyal5508@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rama Kant Yadava |
| Designation |
Additional professor |
| Affiliation |
ALL INDIA INSTITUTE OF AYURVEDA |
| Address |
6th Floor (614) Department Of Kayachikitsa All India Institute Of Ayurveda Gautampuri Sarita Vihar New Delhi
South
DELHI
110076
India |
| Phone |
9412148437 |
| Fax |
|
| Email |
drrky68@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rama Kant Yadava |
| Designation |
Additional professor |
| Affiliation |
ALL INDIA INSTITUTE OF AYURVEDA |
| Address |
6th Floor (614) Department Of Kayachikitsa All India Institute Of Ayurveda Gautampuri Sarita Vihar New Delhi
South
DELHI
110076
India |
| Phone |
9412148437 |
| Fax |
|
| Email |
drrky68@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda gautampuri sarita vihar new delhi 110076 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
Gautampuri Sarita Vihar New delhi 110076 |
| Type of Sponsor |
Government medical college |
|
|
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 Priya goel |
All India Institute of Ayurveda |
kayachikitsa opd no. 3 5 7 All India Institute Of Ayurveda Gautampuri Sarita
Vihar New Delhi
110076
South
DELHI
South
DELHI |
8076331854
priyagoyal5508@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIA INSTITUTIONAL ETHICS COMMITTEE |
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 | Classical | | (1) Medicine Name: ERANDADI GHANAVATI, Reference: VANGSENA SAMHITA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: KAISHORA GUGGULU, Reference: SHARANGHAR SAMHITA, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
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Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients presenting with the clinical features of Vatarakta (sandhi shotha(swelling), sandhi shola(pain), sparsh asahatvam (tenderness), twak vaivarnya(discolouration of skin), raga(redness), vidaha(burning sensation), stabdhata(stiffness))
2.Patients either sex between age group of 21-60 yrs.
3.Patients showing the Serum uric acid level 7 -10mg/dl.
|
|
| ExclusionCriteria |
| Details |
1.Uncontrolled Diabetes and uncontrolled HTN
2.Subjects pre-diagnosed with autoimmune and infective disease of joints. E.g. tuberculous arthritis
3.Malignancy
4.Genetic Disorder e.g. Duchene muscular dystrophy
5.Pregnant and lactating women
6.History of hypersensitivity to any of the trial drug ingredient.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| •Improvement in the signs & symptoms (sandhi shotha(swelling)sandhi shola(pain), sparsh asahatvam (tenderness), twak vaivarnya(discolouration of skin), raga(redness), vidaha(burning sensation), stabdhata(stiffness)) of Vatarakta (Chronic Gout). |
BASELINE
AFTER 6 WEEKS
AFTER 12 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in the level of serum uric acid in the patients having Vatarakta (Chronic Gout). (approx 25% improvement is expected)
Improvement in the quality of life of the patient. |
BASELINE
AFTER 6 WEEKS
AFTER 12 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
25/08/2024 |
| 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 - NO
|
|
Brief Summary
|
RESEARCH QUESTION: - In patients of 21-60 years What is the effect of Erandadi Ghana vati after Virechan over Kaishora guggulu after Virechan in the management of Vatarakta (Chronic Gout)? HYPOTHESIS Improvement in the cardinal symptoms of Vatarakta and decrease in Serum uric acid levels and improvement in the quality of life of patient by internal administration of Erandadi ghana vati after virechan in the management of Vatarakta(Chronic gout). NULL HYPOTHESIS(H0) Erandadi ghanavati is equally effective as Kaishora guggulu after Virechan in the management of Vatarakta (Chronic Gout).
ALTERNATE HYPOTHESIS(H1) Erandadi ghanavati is not equally effective as Kaishora guggulu after virechan in the management of Vatarakta (Chronic Gout).
NEED FOR THE STUDY Many research works on Vatarakta reveals that the Ayurvedic treatment protocol is very effective in reducing the signs and symptoms of the patient by both sodhana and shamana.we have to explore the shamana medicines in the management of Vatarakta in the present era. To find a cost effective,easily available ,better efficacious shamana aushadha and shodhana in the management of Vatarakta we have to carry out the study. Here I am using erandadi ghanavati after Virechan and compare it with Kaishora guggulu after Virechana in the management of Vatarakta(Chronic Gout).
OBJECTIVE OF RESEARCH PROJECT PRIMARY OBJECTIVES: To improve the signs & symptoms (sandhi shotha(swelling ,sandhi shoola(pain), sparsh asahatvam (tenderness), twak vaivarnya(discolouration of skin), raga(redness), vidaha(burning sensation), stabdhata(stiffness)) of Vatarakta (Chronic Gout) and reduction in the level of serum uric acid in the patients having Vatarakta(Chronic Gout)
SECONDARY OBJECTIVES: Improve the Quality of life of the patient (SF 36).
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