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CTRI Number  CTRI/2021/08/036066 [Registered on: 31/08/2021] Trial Registered Prospectively
Last Modified On: 19/02/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Clinical trial on knee pain  
Scientific Title of Study   A randomized, double blind, placebo controlled, cross over study to evaluate the safety and efficacy of a herbal capsule in patients with recent onset of mild to moderate joint knee pain 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
RRS/CL/PL/JH/2021 Version no 1.0 Dated 26 March 2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashok Godavarthi 
Designation  C E O 
Affiliation  Radiant Research Services Pvt. Ltd 
Address  RADIANT RESEARCH SERVICES PVT. LTD. Plot No:99 A, 8th Main Road, III Phase, Peenya Industrial Area, Bengaluru, 560058 Karnataka, India.

Bangalore
KARNATAKA
560058
India 
Phone  9880999297  
Fax    
Email  ashok@radiantresearch.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashok Godavarthi 
Designation  C E O 
Affiliation  Radiant Research Services Pvt. Ltd 
Address  RADIANT RESEARCH SERVICES PVT. LTD. Plot No:99 A, 8th Main Road, III Phase, Peenya Industrial Area, Bengaluru, 560058 Karnataka, India.


KARNATAKA
560058
India 
Phone  9880999297  
Fax    
Email  ashok@radiantresearch.in  
 
Details of Contact Person
Public Query  
Name  DrSasi Kumar Kuttappan 
Designation  Chief Scientific Officer 
Affiliation  Plant Lipids Private Limited 
Address  Plant Lipids Private Limited Kolenchery, Cochin Kerala India

Ernakulam
KERALA
682311
India 
Phone  9586467677  
Fax    
Email  sasikumar.kuttappan@plantlipids.com  
 
Source of Monetary or Material Support  
Plant Lipids Private Limited Kolenchery, Cochin – 682 311, Kerala, India 
 
Primary Sponsor  
Name  Plant Lipids Private Limited 
Address  Kolenchery, Cochin – 682 311, Kerala, India 
Type of Sponsor  Other [Herbal and Nutraceutical company ] 
 
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 
DrPrakashappa T H  Sri Venkateshwara Hospitals   second floor Room number 2 27, 29th Main Road, Rashtra Kuvempu Nagara, BTM 2nd stage, BTM layout, PIN-560076,Bangalore KARNATAKA
Bangalore
KARNATAKA 		 9148103232

svhethics@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Venkateshwara Hospitals Ethics commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M235||Chronic instability of knee. Ayurveda Condition: Sandhishula,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Herbal (contains Black Pepper oil, Turmeric extract, Sunflower Lecithin, Modified Food starch)., Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 250(mg), Frequency: od, Bhaishajya Kal: Sabhakta, Duration: 1 Weeks, anupAna/sahapAna: Yes(details: ), Additional Information:
(2) Medicine Name: Herbal (contains Black Pepper oil, Turmeric extract, Sunflower Lecithin, Modified Food starch)., Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 250(mg), Frequency: od, Bhaishajya Kal: Sabhakta, Duration: 1 Weeks, anupAna/sahapAna: Yes(details: ), Additional Information:
2Comparator ArmDrugOther than Classical(1) Medicine Name: Placebo (Starch), Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 250(mg), Frequency: od, Bhaishajya Kal: Sabhakta, Duration: 1 Weeks, anupAna/sahapAna: Yes(details: ), Additional Information:
(2) Medicine Name: Placebo (Starch), Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 250(mg), Frequency: od, Bhaishajya Kal: Sabhakta, Duration: 1 Weeks, anupAna/sahapAna: Yes(details: ), Additional Information:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details 
1) Volunteer aged between 18-55 years (both inclusive)
2) Knee joint pain since 1 month
3) Willingness to follow the protocol requirement as evidenced by written, informed consent.
4) Willingness to complete study questionnaires.
5) Agree not to use any medication (prescription and over the counter), including vitamins and minerals, during the course of this study.
6) Subjects whose blood chemistries are within a normal range or not considered clinically significant if outside the normal range.
 
 
ExclusionCriteria 
Details  1) Any clinically significant medical history, medical finding or an ongoing medical or psychiatric condition exists which in the opinion of the Investigator could jeopardize the safety of the subject, impact validity of the study results or interfere with the completion of study according to the protocol
2) Significant abnormal findings as determined by baseline history, physical examination, vital signs (blood pressure, pulse rate, respiration rate) hematology, serum chemistry.
3) Diabetes mellitus and other auto-immune disorders like Rheumatoid Arthritis
4) Use of drugs that interfere with gastrointestinal motility and cardiac diseases
5) History of hypersensitivity reactions
6) History or presence of significant alcoholism or drug abuse in the past one year.
7) Participation in a clinical study during the preceding 90 days.
8) Previous abdominal surgery (except appendectomy)
9) Any contraindication to blood sampling.
10) Blood or blood products donated in past 30 days prior to study supplement administration.
11) Female subjects on pregnancy and lactating women
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
i. Decrease in elevated baseline inflammatory and pain markers.
ii. Decrease in elevated baseline anxiety markers.
iii. Decrease in the pain and stress symptoms evaluated through questionnaire
 		 Day-7,Day 0 and Day 8 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the efficacy of herbal capsule in both stress/anxiety parameters  Day 0 and Day 8 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   01/09/2021 
Date of Study Completion (India) 16/09/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Curcumin is the active chemical in turmeric root; it blocks inflammatory cytokines and enzymes in two inflammatory pathways. Several human trials have shown an anti-inflammatory benefit, which can translate to reduced joint pain and swelling. The yellow spice is popular in curries and other Indian dishes. Black pepper contains the bioactive compound piperine, which is an alkaloid like capsaicin, the active component found in chili powder and cayenne pepper. Piperine has been shown to help relieve nausea, headaches and poor digestion and also has anti-inflammatory properties. Still, its most significant benefit may be its ability to boost the absorption of curcumin. Research supports that combining the piperine in black pepper with the curcumin in turmeric enhances curcumin absorption by up to 2,000%. Nuts and seeds are a great dietary source of vitamin E and oils derived from sunflower seeds are rich in vitamin E. Evidence suggests that increasing the intake of vitamin K sources such as kale, spinach, broccoli and Brussels sprouts may also benefit people with osteoarthritis. 
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