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
|
|
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
|
|
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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