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CTRI Number  CTRI/2012/05/002647 [Registered on: 11/05/2012] Trial Registered Retrospectively
Last Modified On: 19/07/2012
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A clinical trial to study the effect of an Ayurvedic Formulation in patients with musculoskeletal pains 
Scientific Title of Study   A Single Centre, Prospective, Open labeled Study to Evaluate Safety & Efficacy of NHPL/OZ-01 an Ayurvedic Formulation in patients with Musculoskeletal Pains 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sridhar 
Designation  MD(Ayu) 
Affiliation  Holistic Health Care & Research Centre 
Address  #3-1-230, Nimboliadda, Kachiguda, Hyderabad-500027, A.P.India

Hyderabad
ANDHRA PRADESH
500027
India 
Phone  9290638805  
Fax    
Email  sjmnaidu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ms Sujata A 
Designation  Manager Medical Services 
Affiliation  NuZen Herbal Private Limited 
Address  Plot no.29, Road no.76, Jubliee Hills, Hyderabad – 500096 Andhra Pradesh – India

Hyderabad
ANDHRA PRADESH
500033
India 
Phone  91-40-30616535  
Fax  91-40-30616535  
Email  sujata@nuzen.in  
 
Details of Contact Person
Public Query  
Name  Ms Sujata A 
Designation  Manager Medical Services 
Affiliation  NuZen Herbal Private Limited 
Address  Plot no.29, Road no.76, Jubliee Hills, Hyderabad – 500096 Andhra Pradesh – India

Hyderabad
ANDHRA PRADESH
500033
India 
Phone  91-40-30616535  
Fax  91-40-30616535  
Email  sujata@nuzen.in  
 
Source of Monetary or Material Support  
NuZen Herbal Private Limited 
 
Primary Sponsor  
Name  NuZen Herbal Private Limited 
Address  Plot no.29, Road no.76, Jubliee Hills, Hyderabad – 500096 Andhra Pradesh – India  
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Sridhar  Holistic Health Care & Research Centre  #3-1-230, Nimboliadda, Kachiguda, Hyderabad-500027, A.P.India
Hyderabad
ANDHRA PRADESH 		 9290638805

sjmnaidu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bezawada Central Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Musculoskeletal Pains,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  N/A  N/A 
Intervention  NHPL/OZ-01 Ayurvedic Formulation  50 ml liquid orally once daily Duration of study: 30 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Subjects of either sex
2. Age above 18 years
3. Willing to give written consent
4. Subjects suffering from Musculoskeletal pains: Myalgia, Neck pain, limb pain, low back pains, Joint Pains, Stiffness and Wide spread musculoskeletal pains.
5. Pain score of at least 4 cm on a 10-cm linear visual analogue scale
 
 
ExclusionCriteria 
Details  1 Contraindications or Hypersensitivity to the active substances or to any of the excipients of the drug.
2 Subjects currently on any other NSAID therapy.
3 History or presence of any medical condition or disease according to the discretion of the Investigator.
4 History of significant renal or hepatic problems / abnormal functions.
5 History of significant asthma, urticaria or other allergic reactions
6 History of significant gastric and/or duodenal ulceration such as Mal-absorption syndrome.
7 History of diabetes, coronary artery disease and hypertension with or without complication
8 History of any chronic physical, hormonal, immune or psychiatric illness
9 Currently taking any herbal preparations
10 Individuals refusing to use appropriate non-hormonal birth control measures.
11 Subjects participating in any other trial.
12 Female subjects found positive in urine pregnancy test.
13 Lactating Mothers
14 Subjects not willing to comply with protocol requirements
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
– At least 50% improvement on the VAS (Visual analogous score) pain from Baseline visit to after Visit 2 & Visit 3 of treatment  Screening,Baseline,Day 10,End of the treatment 
 
Secondary Outcome  
Outcome  TimePoints 
– Safety will be assessed from the number of adverse events occurred and judging their causal relationship to the study drug  Screening,Baseline,Day 10,End of the treatment 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/01/2012 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This study is an open labeled, single centre, Prospective trial to evaluate the Safety & Efficacy of NHPL/OZ-01 Ayurvedic formulation {Composition: Each 50 ml of syrup contains extracts derived from - 1) Haridra (Curcuma longa rhizome) 1gram 2) Pippali (Piper longum fruit) 500 mg 3) Vanya ashwagola (Plantago lanceolata leaves) 1 gram 4) Sthula ela (Amomum subulatum fruit & seeds) 1 gram 5) Kaalmegh (Andrographis paniculata whole plant) 1 gram 6) Tvak (Cinnamomum zeylanicum stem bark) 250 mg 7) Bhutruna (Andropogan citrates leaves) 250 mg} in the treatment of patients with musculoskeletal pains

 
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