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CTRI Number  CTRI/2018/01/011166 [Registered on: 05/01/2018] Trial Registered Prospectively
Last Modified On:
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Leech Application and Agni Karma]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Ayurvedic Management of Joint Pains 
Scientific Title of Study   A CLINICAL STUDY ON AGNIKARMA AND JALAUKA AVACHARANA WITH ABHA GUGGULU IN MANAGEMENT OF SANDHIGATA VATA (OSTEOARTHRITIS OF KNEE JOINT) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vyasadeva Mahanta 
Designation  Associate Professor 
Affiliation  All India Institute of Ayurveda 
Address  OPD No 104, First Floor, Hospital Block, Dept of Shalya Tantra, All India Institute of Ayurveda, Gautampuri, Sarita Vihar

South
DELHI
110076
India 
Phone    
Fax    
Email  drvyasayu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sanjay Kumar Gupta 
Designation  Professor 
Affiliation  All India Institute of Ayurveda 
Address  OPD No 104, First Floor, Hospital Block, Dept of Shalya Tantra, All India Institute of Ayurveda, Gautampuri, Sarita Vihar

South
DELHI
110076
India 
Phone    
Fax    
Email  drskgupta17@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Saroj Meena 
Designation  PG Scholar 
Affiliation  All India Institute of Ayurveda 
Address  OPD No 104, First Floor, Hospital Block, Dept of Shalya Tantra, All India Institute of Ayurveda, Gautampuri, Sarita Vihar

South
DELHI
110076
India 
Phone    
Fax    
Email  sarojmeenajpr007@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Ayurveda, Gautampuri, Sarita Vihar 
 
Primary Sponsor  
Name  All India Institute of Ayurveda 
Address  Gautampuri, Sarita Vihar, New Delhi - 110076 
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 Vyasadeva Mahanta  All India Institute of Ayurveda  OPD No 104, First Floor, Hospital Block, Dept of Shalya Tantra, All India Institute of Ayurveda, Gautampuri, Sarita Vihar
South
DELHI 
8368104072

drvyasayu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  joint pain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Abha Guggulu and Agnikarma  1 gm of Abha Guggulu thrice a day with like warm water after food will be administered for 30 days. Besides, agnikarma with Pancha dhatu Shalaka will be done once in a week, maximum four sittings will be done.  
Comparator Agent  Abha Guggulu and Jalaukavacharana  1 gm of Abha Guggulu thrice a day with like warm water after food will be administered for 30 days. Besides this; Jalauka avacharana with 04 Jalaukas in 1 sitting will be done once in a week, maximum four sittings will be done. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients suffering from Sandhigata Vata (Osteoarthritis of knee joint). 
 
ExclusionCriteria 
Details  Patients with Knee joint effusion, Known cases of secondary OA due to TB, Syphilis etc.; suffering with Diabetes mellitus, Severe anaemia, malignancy, bleeding disorders etc. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the comparative clinical efficacy of Agnikarma and Jalauka Avacharana of
Management of Sandhigata Vata 
30 days 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in quality of life  2 Months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 2/ Phase 3 
Date of First Enrollment (India)   02/04/2018 
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   The outcome will be disseminated among peer reviewed journals. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Osteoarthritis (OA) is predominantly a disease of the elderly but no age is exempted. It is caused by wear and tear of the joint. In OA, the top layer of cartilage breaks down and wears always. Worldwide OA is the most common joint disorder. OA is the commonest from of joints disease which is a painful and disabling in advancing years of life. Before 60 years of age 10 out of 100 and after 60 years 75 out of 100 persons suffers from OA of knee joints. After 60 years of age, this disease creates so much trouble that medical consultation becomes mandatory. Worldwide OA is the most common articular disease of people of 65 years and above.

In Ayurveda OA can be correlated with Sandhigata Vata. It is characterised by the symptoms of Shotha (swelling), Shula (pain), Vata Purna Driti Sparsha (palpable as an air filled bag) and Akunchana Prasarane Vedana (pain on flexion and extension of the joint), Hantisandhi (structural changes) and Atopa (crepitus).

In modern medicine various treatment options are available like conservative treatment, epidural steroid injection, radicular infiltration, surgical methods but all modalities have their own limitations and certain complications. In Ayurveda, Snehana, Upanaha, Agnikarma, Raktamokshana, Panchakarma, Bheshaja Chikitsa etc. have been recommended in the management of such manifestations. Among these Agnikarma and Raktamokshana have their own therapeutic values in the management of Sandhigata Vata. Jalauka avacharana is a kind of Raktamokshana, which has gained greater attention globally because of its medical values. It is also a procedure adviced in the management of OA.

Abha Guggulu is known for its Shothahara (anti-inflammatory), Shulahara (analgesic), Rasyana (Rejuvenative), Sandhankara (healing properties) actions. It is anticipated to be helpful in the treatment of OA. Though, it is being used in Ayurveda; but no comparative efficacy is available; considering which the current study is planned.  

 
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