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CTRI Number  CTRI/2014/04/004531 [Registered on: 07/04/2014] Trial Registered Prospectively
Last Modified On: 07/04/2014
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 shiva guggulu tablets and kottam chukkadi taila in management of Amavata (one type of joint disorder) 
Scientific Title of Study   A clinical study on the management of Rheumatoid Arthritis with Shiva Guggulu and Kottam Chukkadi Taila 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sherasia Altaf Abdulrahim 
Designation  MD student Ayurveda 
Affiliation  I P G T and R A gujarat ayurved university jamnagar 
Address  Department of Kayachikitsa I P G T and R A Gujarat Ayurved university Jamnagar 361008 Jamnagar GUJARAT 361008 India
Dr Altaf Sherasia village Panchasar near Ambika ceramic Taluka Wankaner Dist Rajkot GUJARAT 361008 India
Jamnagar
GUJARAT
361008
India 
Phone  9033457226  
Fax    
Email  dr.altaf16@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof M S Baghel  
Designation  Director IPGT and RA Jamnagar 
Affiliation  I P G T and R A gujarat ayurved university jamnagar 
Address  Director office first floor IPGT and RA Gujarat Ayurved University jamnagar 361008
Director office first floor IPGT and RA Gujarat Ayurved University jamnagar 361008
Jamnagar
GUJARAT
361008
India 
Phone  9427207964  
Fax    
Email  baghelayu@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Prof M S Baghel  
Designation  Director IPGT and RA Jamnagar 
Affiliation  I P G T and R A gujarat ayurved university jamnagar 
Address  Director office first floor IPGT and RA Gujarat Ayurved University jamnagar 361008
Director office first floor IPGT and RA Gujarat Ayurved University jamnagar 361008
Jamnagar
GUJARAT
361008
India 
Phone  9427207964  
Fax    
Email  baghelayu@rediffmail.com  
 
Source of Monetary or Material Support  
IPGT and RA Jamnagar 
 
Primary Sponsor  
Name  Institute for Post Graduate Teaching and Research in Ayurveda 
Address  I P G T and R A Gujarat Ayurved Universuty Jamnagar 361008 
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 
Dr Altaf Sherasia  Dept. of Kayachikitsa  OPD no. 21 Institute for post graduate teaching and research in Ayurveda Gujarat Ayurved University Jamnagar – 361008 Jamnagar GUJARAT Jamnagar GUJARAT
Jamnagar
GUJARAT 		 9033457226

dr.altaf16@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar – 361008 VIde Ref- PGT/7-A/201 2-2013/1964  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  patients suffering from Rheumatoid Arthritis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Shiva Guggulu tablet Kottam chukkadi taila castor oil and shunthi churna  in group A shiva Guggulu 2 tablets each of 500 mg will be given twice day kottam chukkadi taila for local application Shunthi churna 3 gm in the morning daily castor oil 5 to 10 ml at bed time for 2 months  
Comparator Agent  Shiva guggulu tablets and Shunthi Churna  in group B Shiva Guggulu 2 tablets each of 500 mg will be given twice a day with shunthi churna 3 gm in the morning with castor oil 5 to 10 ml at bed time but kottam chukkadi taila will not be applied for 2 months 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  patients fulfilling the diagnostic criteria
Age between 20 to 60 years
willing and able to participate in the study 
 
ExclusionCriteria 
Details  Chronicity more than 10 years
A patients who have severe complications of Rheumatoid Arthritis
A patients having gouty Arthritis
poorly controlled HTN And DM
Patients on prolong allopathy medication like steroids
pregnant and lactating women
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The effect will be assessed on the basis of
subjective and objective criteria.
Improvement in the signs and symptoms will be
appraised on the basis of special adopted
scoring pattern for scrutinizing the
symptomatology.
Changes in RA factor and CRP
Improvement in Hand grip walking time foot pressure
etc. 		 60 days 
 
Secondary Outcome  
Outcome  TimePoints 
The effect will be assessed on the basis of
subjective and objective criteria. 		 60 days 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   N/A 
Date of First Enrollment (India)   10/04/2014 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Rheumatoid Arthritis is a clinical condition characterized by inflamation of synovial membrane . it closely resembles with Amavata mentioned in Ayurvedic classics madhava nidana. Shiva guggulu as a internal medication and Kottam chukkadi Taila as a local application are helpful to manage the disease  Rheumatoid Arthriti but it takes long time to control the symptoms. contents of Shiva Guggulu and Kottam Chukkadi as below.

A.    SHIVA GUGGULU:-

No.

Name(Latin Name)

Part Used

Proportion

1.

Haritaki (Terminalia chebula)

Fruit

1 part

2.

Bibhitaka (Terminalia bellirica )

Fruit

1 part

3.

Amalaki (Emblica officinalis)

Fruit

1 part

4.

Erand Taila(Ricinus communis)

Oil

1/2 part

5.

Suddha Gandhaka(Sulphur)

-

1/5  part

6.

Suddha Guggulu(Commiphora mukul)

Resin

1/2part

7.

Rasna (Pluchea lanceolata)

Whole plant

1/32  part

8.

Vidanga (Embelia ribes)

Fruit

1/32  part

9.

Maricha (Piper nigrum)

Fruit

1/32  part

10.

Pippali (Piper longum)

Fruit

1/32  part

11.

Danti (Baliospermum montanum)

Root

1/32  part

12.

Jatamansi (Nardostachys jatamansi)

Rhizome

1/32  part

13.

Nagar (Zingiber officinale)

Rhizome

1/32  part

14.

Devadaru (Cedrus deodara)

Heart wood

1/32  part


KOTTAM CHUKKADI TAILA. The ingredients of Kottam Chukkadi Taila are as follow;

No.

Name(Latin Name)

Part Used

Proportion

1.

Kushtha (Saussurea lappa)

Root

1 part

2.

Shunthi (Zingiber officinale)

Rhizome

1 part

3.

Vacha (Acorus calamus)

Rhizome

1 part

4.

Shigru (Moringa oliefera)

Stem bark

1 part

5.

Lashuna (Alium sativum)

Bulb

1 part

6.

Himstra (Capparis sepiaria)

Root

1 part

7.

Devadaru (Cedrus deodara)

Ht.wood

1 part

8.

Sarshapa (Brassica campestries)

Seeds

1 part

9.

Rasna (Vanda roxburghai)

Whole plant

1 part

10.

Tila(Sesamum indicum)

Oil

32 part

11.

 Godadhi(curd)

-

32 part

12

 Chincha (Tamarindus indica)

Leaves

1/7  part

 


 
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