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CTRI Number  CTRI/2014/08/004929 [Registered on: 26/08/2014] Trial Registered Retrospectively
Last Modified On: 26/08/2014
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Efficacy of Amrita Guggulu and Pinda Taila in the Management of GOUT. 
Scientific Title of Study   An open Label efficacy study of Amrita Guggulu and Pinda Taila in the Management of Hyperuricemia in GOUT (Vatarakta) patients. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajesh Sannd 
Designation  Institute Incharge Research Officer (Scientist 3) 
Affiliation  National Institute of Ayurvedic Pharmaceutical Research 
Address  National Institute of Ayurvedic Pharmaceutical Research Moti Bagh Road

Patiala
PUNJAB
147001
India 
Phone  09316223524  
Fax  01752223663  
Email  sanndrajesh@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajesh Sannd 
Designation  R.O. (Scientist 3) 
Affiliation  Central Council for Research in Ayurvedic Sciences (CCRAS) 
Address  National Institute of Ayurvedic Pharmaceutical Research (NIAPR) Moti Bagh Road Patiala

Patiala
PUNJAB
147001
India 
Phone  09316223524  
Fax  01752223663  
Email  sanndrajesh@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rajesh Sannd 
Designation  R.O. (Scientist 3)  
Affiliation  Central Council for Research in Ayurvedic Sciences (CCRAS) 
Address  National Institute of Ayurvedic Pharmaceutical Research (NIAPR) Moti Bagh Road, Patiala
National Institute of Ayurvedic Pharmaceutical Research (NIAPR)
Patiala
PUNJAB
147001
India 
Phone  09316223524  
Fax  01752223663  
Email  sanndrajesh@yahoo.com  
 
Source of Monetary or Material Support  
Central Council for Research in Ayurvedic Sciences (CCRAS) New Delhi 
 
Primary Sponsor  
Name  Central Council for Research in Ayurvedic Sciences CCRAS 
Address  JLNBCEHAB 61 to 65 Institutional area Opp D block Janakpuri New delhi 110058 
Type of Sponsor  Other [Autonomous Research Organisation under Department of AYUSH] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Laxaman Bhurke  ARRI Jammu  Ayurveda Regional Research Institute Rajinder Nagar Ban Talab Jammu 181123
Jammu
JAMMU & KASHMIR 
01912546475
01912546475
dewa2007@rediffmail.com 
Dr Rajesh Sannd  NIAPR Patiala  National Institute of Ayurvedic Pharmaceutical Research Moti Bagh Road
Patiala
PUNJAB 
9316223524
01752223663
sanndrajesh@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethical Committee NIAPR Patiala  Approved 
Institutional Ethical Committee RRI Jammu  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Clinical trial will be conducted on Gout Patients fulfilling the Inclusion criteria,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Amrita Guggulu, Pinda Taila  1 gm BD with luke warm water and 10 ml for local application at the site of pain. The duration of the treatment is 12 weeks with followup after 2 weeks months. 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Confirmed cases of Primary Gouty arthritis fulfilling the diagnostic criteria as recommended by the American College of Rheumatology (1977) it should meet the presence of any six of the following twelve criteria:
i. More than one attack of acute arthritis.
ii. Maximal Inflammation developing within 1 day of onset.
iii. Monoarthritis attack.
iv. Redness over effected joint.
v. Unilateral attack on the first Metatarsophalangeal (Big Toe) joint.
vi. Unilateral attack involving Tarsal joint.
vii. First Metatarsophalangeal (Big Toe) joint, painful or swollen.
viii. Suspected Tophi.
ix. Hyperuricemia (more than 7.0 mg per dl)
x. Asymmetrical swelling within joint (X Ray).
xi. Sub cortical cysts without erosions (X Ray).
xii. Negative culture from joint fluid during attack.
3. Willing and able to participate in the study for 14 weeks
 
 
ExclusionCriteria 
Details  i. History of any trauma or fractured joint or surgical or diagnostic intervention with reference to the affected joint (s).
ii. Patients with comorbidities such as Rheumatoid arthritis Psoriatic arthritis etc.
iii. Patients with poorly controlled Hypertension (> 160/100 mm of Hg).
iv. Patients with poorly controlled Diabetes Mellitus (HbA 1c more than 8.0 percent)
v. Patients with evidence of malignancy.
vi. Patients with unstable cardiovascular disease.
vii. Known cases of Hypothyroidism or hyperthyroidism.
viii. Patients with any concurrent hepatic disorder (defined as liver enzymes SGOT or SGPT more than 2 times upper normal limit) or Renal Disorders (defined as S. Creatinine more than 1.4 mg per dl) or Severe COPD.
ix. Alcoholics/drug abusers.
x. History of hypersensitivity to any of the trial drugs or their ingredients.
xi. Pregnant or lactating woman.
xii. Any other condition which the Investigator thinks may jeopardize the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Mean percentage decrease in Serum Uric Acid levels from the base line to the end of study period.  12 weeks regimen and followup for 2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in SF-36 Health Survey score, Patients Global Assessment, Physicians global Assessment, pain VAS scale.

To assess the safety of the trial drug by lab parameters and observing any occurrence of any ADR or AE. 
12 weeks regimen and followup for 2 weeks 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 3 
Date of First Enrollment (India)   12/11/2012 
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)  Closed to Recruitment of Participants 
Publication Details   Yet to be published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
Vatarakta is major disorder of Vata & Rakta. Acharya Caraka has classified in two types- 1. Uttana, 2. Gambhira. Signs and symptoms of Utthana Vatarakta are Kandu, daaha, rujaa, toda, sphurana and darkening of skin. The signs and symptoms of Gambhira Vatarakta are Shotha (inflammation), kaathinya, vedanaadhikya, daaha, toda, bheda, sphurana, paaka and joint deformity in later stage. When all the symptoms and signs of both the types are present it is called as Ubhayagat Vatarakta. Acharya Sushruta considers these as stages of Vatarakta instead of types.
On the basis of the symptomatology, Vatarakta can be correlated with the desease condition Gout. Gout is a rheumatic disease resulting from deposition of uric acid crystals (monosodium urate) in tissues and fluids within the body. This process is caused by an overproduction or under excretion of uric acid.
The drugs Amritadi Guggulu and Pinda Taila are among various drugs mentioned in ayurveda that help to treat Vatarakta. This study is aimed to establish their role in treating gout and establish their safety by assessing modern parameters.
The contents of these drugs are:
Amritadi Guggulu consists:
1. Guggulu (Resin of Commiphora mukul), 
2. Triphala (fruit pilp of Terminalia chebula Retz, Terminalia bellirica, Emblica officinalis),
3. Guduchi (Stem of Tinospora cordifolia)
4. Danti (Root of Baliospermum montanum)
5. Trikatu ( Fruit of Piper longum, Piper nigrum, Zingiber officinale)
6. Vidanga ( Fruit of Embelia ribes)
7. Tvak (Stem bark of Cinnamomum zeylanicum)
8. Trivrit (Root of Operculina turpethum)
Pinda Taila consists:
1. Mdhuchhishta (Beewax), 
2. Manjistha, (Root of Sida cordifolia)
3. Sarjarasa (Resin of Shorea fobusta Gaertn. f.)
4. Sariva (Root of Hemidesmus indicus).
5. Til taila (Sesmum oil)
The objective of the trial is to validate and establish the clinical efficacy of these classical ayurvedic formulations on scientific basis to establish its safety in the treated subjects.

 
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