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
|
|
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
|
|
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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