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CTRI Number  CTRI/2015/01/005414 [Registered on: 15/01/2015] Trial Registered Prospectively
Last Modified On: 15/02/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   EFFECT OF RASNADI GUTIKA AND CHANDRAKALA LEPA IN OSTEOARTHRITIS KNEE 
Scientific Title of Study   THERAPEUTIC EVALUATION OF RASNADI GUTIKA AND CHANDRAKALA LEPA IN JANU SANDHIGATA VATA(OSTEO ARTHRITIS KNEE) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  BANAMALI DAS 
Designation  RESEARCH OFFICER(AYURVEDA) 
Affiliation  NATIONAL RESEARCH INSTITUTE OF AYURVEDA DRUG DEVELOPMENT 
Address  BHARATPUR, BHUBANESWAR, KHORDHA, ODISHA, INDIA, PIN-751003
BHARATPUR, BHUBANESWAR, KHORDHA, ODISHA, INDIA, PIN-751003
Khordha
ORISSA
751003
India 
Phone  0674-2386435  
Fax  0674-2386435  
Email  banamali.d@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  BANAMALI DAS 
Designation  RESEARCH OFFICER(AYURVEDA) 
Affiliation  NATIONAL RESEARCH INSTITUTE OF AYURVEDA DRUG DEVELOPMENT 
Address  BHARATPUR, BHUBANESWAR, KHORDHA, ODISHA, INDIA, PIN-751003
BHARATPUR, BHUBANESWAR, KHORDHA, ODISHA, INDIA, PIN-751003
Khordha
ORISSA
751003
India 
Phone  0674-2386435  
Fax  0674-2386435  
Email  banamali.d@gmail.com  
 
Details of Contact Person
Public Query  
Name  BANAMALI DAS 
Designation  RESEARCH OFFICER(AYURVEDA) 
Affiliation  NATIONAL RESEARCH INSTITUTE OF AYURVEDA DRUG DEVELOPMENT 
Address  BHARATPUR, BHUBANESWAR, KHORDHA, ODISHA, INDIA, PIN-751003
BHARATPUR, BHUBANESWAR, KHORDHA, ODISHA, INDIA, PIN-751003
Khordha
ORISSA
751003
India 
Phone  0674-2386435  
Fax  0674-2386435  
Email  banamali.d@gmail.com  
 
Source of Monetary or Material Support  
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES, NO 61-65, INSTITUTIONAL AREA, JANAKPURI, NEW DELHI,-110058 
 
Primary Sponsor  
Name  CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES JANAKPURI NEW DELHI 
Address  CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES, NO 61-65, INSTITUTIONAL AREA, JANAKPURI, NEW DELHI,-110058 
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 = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR BANAMALI DAS  NATIONAL RESEARCH INSTITUTE OF AYURVEDA DRUG DEVELOPMENT, BHUBANESWAR  BHARATPUR, BHUBANESWAR, ODISHA, INDIA
Khordha
ORISSA 		 9439956684
0674-2386435
banamali.d@gmail.com 
DR SANJAY KUMAR SINGH  NATIONAL VETERINARY AYURVEDIC RESEARCH INSTITUTE & HOSPITAL, LUCKNOW  INDIRANAGAR, SECTOR 25, LUCKNOW, UTTAR PRADESH-226016
Lucknow
UTTAR PRADESH 		 9532013013
0522-2717801
drsksingh2005@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, NRIADD, BHUBANESWAR  Approved 
INSTITUTIONAL ETHICS COMMITTEE, NVARI&H, LUCKNOW  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  PAIN AND STIFFNESS OF THE KNEE JOINTS,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
Intervention  RASNADI GUTIKA AND CHANDRAKALA LEPA FOR THE SAME SET OF PATIENTS IN A SINGLE GROUP.  A. Rasnadi Gutika (AFI – Part III ). Dose 2 Tablets (01 Gram) twice daily Dosage form- Tablet of 500 mg each Route of Administration -Oral Time of Administration- Twice a day after food Anupana-Lukewarm Water Packing form: Jar containing 60 Tablets Duration of therapy-03 months B. Chandrakala Lepa (AFI – Part III). Dose Dose: About 10 ml Dosage form-Lepa(Local application) Route of Administration- Local application on the affected parts Time of Administration- Twice a day in the affected part Packing form-300 gms plastic bottle Duration of therapy-03 months  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1) Patients of either sex aged between 40 and 75 years.
2) Patient with primary osteoarthritis Knee joint(s) fulfilling the diagnostic criteria of osteoarthritis recommended by the American College of Rheumatology; i.e. Knee pain and; At least three of the following 6 criteria: 50 years of age or older, stiffness lasting less than 30 minutes, crepitus, bony tenderness, bony enlargement, no warmth to the touch
3) Pain in the affected Knee joint(s) > 3 months (with radiological changes as per Grade I to III of Kellgren & Lawrence Radiological scale) i.e.
Grade 1: Narrowing is defined as doubtful narrowing of joint space and possible osteophytic
lipping.
Grade 2: Osteophytes and definite narrowing of joint space.
Grade 3: Moderate multiple osteophytes, definite narrowing of joint space, some sclerosis and
possible deformity of bone ends.
4) Willing and able to participate in the study for 03 months.
 
 
ExclusionCriteria 
Details  1. Patients with Grade IV Kellgren & Lawrence Radiological scale i.e.
Grade 4: Large osteophytes, marked narrowing of joint space, severe sclerosis and definite deformity of bone contour.
2. History of any trauma/ fractured joint / surgical/diagnostic intervention with reference to the affected joint(s).
3. Gross disability in performing daily normal routine i.e. bed ridden patients or confined to a wheelchair.
4. Patients with co morbidities such as gouty arthritis, rheumatoid arthritis and psoriatic arthritis.
5. Patients having any deformity of knee hip or back altering the gait and posture of the patient.
6. Patients with Unstable cardiovascular diseases.
7. Patients with uncontrolled diabetes mellitus {HbA1c>6.5%}.
8. Patients with evidence of malignancy.
9. Patients on prolonged (> 6 weeks) medication with corticosteroids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study.
10. Patients with any severe renal or hepatic or any other disorder which may interfere in the study.
11. Pregnant / lactating woman.
12. Patients who have participated in other clinical trials within two months of duration.
13. Any other condition which the Principal Investigator thinks may jeopardize the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
• Change in WOMAC total score(CRD, Pune version) (At the time of baseline and at the end of the treatment).   Total Study Period 24 months
Preparatory Period 3 months
Recruitment 18 months
Treatment Period 3 months
Statistical Analysis 3 months
 
 
Secondary Outcome  
Outcome  TimePoints 
• Change in WOMAC stiffness Domain Score
• Change in WOMAC Physical function Domain .
• Change in WHO QOL BREF Scale (At the time of baseline and at the end of the treatment).
• Assessment of change in the Clinical Parameters (On 0, 14th, 28th, 42nd, 56th, 70th and 84th day).
• Changes in analgesic burden in comparison to baseline (No. of times of use of conventional analgesic drug). [Time frame: at baseline and end of the treatment].
 		 Total Study Period 24 months
Preparatory Period 3 months
Recruitment 18 months
Treatment Period 3 months
Statistical Analysis 3 months
 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/04/2015 
Date of Study Completion (India) 25/02/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Submitted for publication 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  		 THE TRIAL IS IN THE EARLY PHASE AND IS NOT YET STARTED. The present study the drugs Rasnadi Gutika (Ref:AFI, Part-III, Page-111) contains Rasna, Guggulu and Sarpi. According to Ayurveda, Rasna is a well known drug for Vatashamana (which alleviates Vata). Moreover it’s anti-inflammatory, analgesic, immunostimulating and antioxidant effect also have been reported. (IJNPR Vol.-I(2)[Junw-2010]). Guggulu is also Vatahara (subsides the aggravated Vata dosha), Shulahara (relieves pain) and it’s anti-inflammatory activity and effectiveness in Osteoarthritis has been reported. (Alternative therapies in health and Medicine, May/June,2003, Vol.-9, No.3). Sarpi is Vata Shamaka, and Brumhaniya(Ca.Su. 13/4).

Chandrakala Lepa (Ref:AFI, Part-III, Page-225) contains Madhuchhista, Sveta Maricha, Coconut Oil, and Karpura. Madhuchhista and Coconut Oil, being snigdha (unctuous) in nature decreases rukshata (roughness) in the joints. Sveta Maricha and Karpoora, both are shula nashaka (relieves pain) and can act effectively in Sandhivata.

Warm Water (as anupana) is Vatahara (subsides the aggravated Vata dosha) and Shulanashaka (relieves pain). Due to its Ushna (hot nature) and Teekshna (sharpness)  properties, it acts as Sroto shodhaka (make clarity of the channels in the body), by which Vata anulomana (subside of aggravated Vata dosha) occurs and it helps the drugs to act properly in the proper site.

Therefore both the above drugs are taken into the specific disease condition with the hypothesis that, to act effectively for the proper Samprapti vighatana (disintegration of the pathogenesis of the disease), by alleviating Vata and Shula, which are the main complaints of the disease. 
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