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CTRI Number  CTRI/2022/03/041247 [Registered on: 22/03/2022] Trial Registered Prospectively
Last Modified On: 21/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Homeopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Acute management of joints pain by homoeopathic medicine Berberis vulgaris 
Scientific Title of Study   A prospective comparative study to analyze the effects of Berberis vulgaris in acute management of Arthralgia by sublingual and external route of administration 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nupur Kumari 
Designation  PG student 
Affiliation  Swasthya Kalyan Homoeopathic Medical College and Research Centre 
Address  Swasthya Kalyan Homoeopathic Medical College and Research Centre sitapura Jaipur Rajasthan

Jaipur
RAJASTHAN
302022
India 
Phone  8094944945  
Fax    
Email  shahnupurshah@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Neelima Singh 
Designation  Assistant Professor 
Affiliation  Swasthya Kalyan Homoeopathic Medical College and Research Centre 
Address  Swasthya Kalyan Homoeopathic Medical College and Research Centre sitapura Jaipur Rajasthan
Sitapura Industrial area Tonk road Jaipur Rajasthan
Jaipur
RAJASTHAN
302022
India 
Phone    
Fax    
Email  dr.neelimasingh.4@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nupur Kumari 
Designation  PG student 
Affiliation  Swasthya Kalyan Homoeopathic Medical College and Research Centre 
Address  Swasthya Kalyan Homoeopathic Medical College and Research Centre sitapura Jaipur Rajasthan

Jaipur
RAJASTHAN
302022
India 
Phone  8094944945  
Fax    
Email  shahnupurshah@gmail.com  
 
Source of Monetary or Material Support  
Swasthya Kalyan Homoeopathic Medical College and Research Centre Jaipur 
 
Primary Sponsor  
Name  Dr Nupur Kumari 
Address  Swasthya Kalyan Homoeopathic Medical College and Research Centre Tonk road sitapura Jaipur Rajasthan 
Type of Sponsor  Other [Self] 
 
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 Nupur Kumari  Swasthya Kalyan Homoeopathic Medical College and Research Centre  College Hospital OPDs Riico industrial area Tonk road sitapura Jaipur Rajasthan
Jaipur
RAJASTHAN 
8094944945

shahnupurshah@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee SKHMCRC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Berberis vulgaris  Medicines are administered by sublingual and external route of administration. The total duration of study will be 21 days. 
Intervention  Berberis vulgaris  Sublingual, 4 globules and external route, 1ml rubbed on surface. The patient will be under observation for 45 minutes on the first day of visit and will note down the intensity of pain in this duration. This will be for both routes of administration. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients having history of pain in joints with associated symptoms of joint disease 
 
ExclusionCriteria 
Details  Recent fractured or any congenital disorders
Patients with severe systemic illness
Pregnant and lactating women 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Obtained from the Visual Analog Scale (VAS) score  In 21 days  
 
Secondary Outcome  
Outcome  TimePoints 
If patient doesnt response to prescribed medicine, can be liable to refer to other doctor or can be prescribed the constitutional medicines for the same.  Will wait for 21 days for the action ofthe prescribed medicine 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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   N/A 
Date of First Enrollment (India)   01/04/2022 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Arthralgia is a symptom of the chronic manifestation of the diseases. Usually homoeopathy is overlooked for pain management but it has a very wide action in acute cases as our master Dr Hahnemann has mentioned in aphorisms 72 & 73. Many homeopathic medicines used for various types of pain like back pain, dental pain, labor pains, and neuralgia. A severe acute trauma can respond to the same homeopathic medicine in nearly all individuals.
Many literatures has shown that Berberis vulgaris acts in gouty constitutions or rheumatic affections. The choice of administration route; based on practical aspects and patient’s consent. The drug has to cross several cellular barriers (or membranes) and diffuse in intercellular spaces to reach the bloodstream. The sublingual routes allow drugs to be delivered directly into the systemic circulation, thus avoiding the portal vein system and liver filtration. These drugs quickly cross the multilayered epithelium of the tongue; this muscular organ is highly vascularized, thus allowing fast absorption and rapid appearance of therapeutic effects. Several factors influence skin absorption, the most important being skin integrity, thickness and hydration, and local blood flow.
Skin is the largest organ of the body so the action of the medicines took place by rubbing on surface hence stimulate the inner layer of skin i.e. Dermis specially the superficial papillary layer which projects into epidermis and contain blood vessels, lymphatics and nerve fibres. Rubbing-in appears in favour the action of medicine only in this way that friction makes the skin more sensitive and the living fibres thereby more capable of feeling, as it were, the medicinal power and of communicating to the whole organism this health-affecting sensation. Dr Hahnemann spokes about external application in aphorism 254 of 6th edition of organon.

 
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