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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  
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 
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  
Status 
Not Applicable 
 
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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