CTRI Number |
CTRI/2017/12/010844 [Registered on: 12/12/2017] Trial Registered Retrospectively |
Last Modified On: |
24/11/2017 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
to compare the efficiency of some herbal drugs in the treatment of amavata |
Scientific Title of Study
|
Comparative Study of Efficacy of “Shiva Guggulu†and “Alambushadi Ghan Vati†in the Management of Amavata with special reference to Rheumatoid Arthritis. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Prof Ram Kishor Joshi |
Designation |
HOD and Professor |
Affiliation |
National Institute of Ayurveda |
Address |
Department of Kayachikitsa National Institute of Ayurveda near Jorawar singh gate madhav vilas palace Amer road Jorawar Singh gate, Madhav Vilas palace, Amer road Jaipur RAJASTHAN 302002 India |
Phone |
9414322297 |
Fax |
|
Email |
joshirk1964@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Prof Ram Kishor Joshi |
Designation |
HOD and Professor |
Affiliation |
National Institute of Ayurveda |
Address |
Department of kayachikitsa National Institute of Ayurveda near Jorawar singh gate madhav vilas palace Amer road Jorawar Singh gate, Madhav Vilas palace, Amer road Jaipur RAJASTHAN 302002 India |
Phone |
9414322297 |
Fax |
|
Email |
joshirk1964@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Kumari Priya |
Designation |
PG scholar |
Affiliation |
National Institute of Ayurveda |
Address |
Depatment of Kayachikitsa National Institute of Ayurveda near Jorawar Singh gate, Madhav Vilas palace, Amer road near Jorawar Singh gate, Madhav Vilas palace, Amer road Jaipur RAJASTHAN 302002 India |
Phone |
9453252300 |
Fax |
|
Email |
kumari.drpriya@gmail.com |
|
Source of Monetary or Material Support
|
National Institute of Ayurveda ,jorawar singh gate, Amer road, Jaipur |
|
Primary Sponsor
|
Name |
National Institute of Ayurved |
Address |
near Jorawar Singh gate, Madhav Vilas palace, Amer road |
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 |
Prof Ram Kishor Joshi |
National Institute of Ayurveda |
Department of kayachikitsa Jorawar Singh gate, Madhav Vilas palace, Amer road Jaipur RAJASTHAN |
9414322297
joshirk1964@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
IEC,NIA |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
amavata ( rheumatoid arthritis), |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Alambushadi ghan vati |
2 Tab (each Tab 500 mg), three times in a day with lukewarm water, after meal for 30 days |
Intervention |
shiva guggulu |
2 Tab (each Tab 500mg.) three times in a day with lukewarm water, after meal for 30 days |
|
Inclusion Criteria
|
Age From |
16.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1. The patients between the age group of 16 to 60 years in either sex presenting with clinical features of Amavata (R.A.).
2. Pre-diagnosed patient of Amavata. (Chronicity < 4 years)
3. Patient willing to sign the consent forms.
|
|
ExclusionCriteria |
Details |
1. Patients having severe crippling bone deformities.
2. Patients suffering from paralysis.
3. Patients having any type of arthopathy such as neoplasm of spine, Gout, Ankylosing spondylosis, traumatic arthritis and pyogenic Osteomylitis etc.
4. Patients having associated Cardiac disease, Tuberculosis, Diabetes Mellitus, Malignant Hypertension, Renal Function Impairment; Hypothyroidism, RHD etc.
5. Patients with extremely reduced joint space.
6. Pregnant women and lactating mother.
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Patients of either sex 16-60 yr old diagnosed with amavata (rheumatoid arthritis) will be selected for relief in sign and symptoms |
30 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
Assess comparative efficacy of shiva gutika and alambushadi ghan vati in amavata (rheumatoid arthritis) |
30 days |
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
|
23/11/2016 |
Date of Study Completion (India) |
10/03/2017 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
journal of ayurvedic holistic medicine (JAHM) vol 5 issue 5 |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
The clinical presentation of Amavata closely mimics with the special variety of Rheumatologic disorders called rheumatoid arthritis (R.A.). Prevalence of RA is approx. 0.8 % of the population. Due to wide spectrum of disease, much prevalence in the society and lack of effective medicine, the disease had been chosen for the study. Aim- To compare the efficacy of “Shiva Guggulu†and “Alambushadi Ghan Vati†in the management of Amavata (R.A.). Settings and Design: Single Centered, Open Labeled, Randomized Clinical Study. Methods and Material: 50 clinically diagnosed patients of Amavata and who fulfilled the criteria of inclusion and willing to participate in trial were registered for present clinical trial and divided into two groups by simple randomization method (Lottery method). Group A- 25 patients of Amavata were administered ‘Shiva Guggulu’ 2 Tab (each Tab 500 mg.) thrice in a day with lukewarm water, after meal for 30 days Group B- 25 patients of Amavata were administered ‘Alambushadi Ghan Vati’ 2 Tab (each Tab 500 mg) thrice in a day, with lukewarm water, after meal for 30 days. Statistical analysis used: In Stat Graph Pad 3 Software was used for statistical analysis. For Nonparametric data Wilcoxon matched-pairs signed ranks test while for Parametric data Paired‘t’ Test and for Inter group comparison, Mann-Whitney Test & Unpaired ‘t’ Test were used. Conclusion: On comparing the effect of two therapies it can be concluded that Group B (Alambushadi Ghana Vati) provided better relief statistically than Group A (Shiva Guggulu) in most of the sign and symptom of the disease. It also considerably prevents the relapse.
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