| CTRI Number |
CTRI/2024/06/068329 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
05/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homeopathy in haemorrhoids |
|
Scientific Title of Study
|
A clinical prospective study of the miasmatic understanding in cases of haemorrhoids managed with individualised homeopathic medicines |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Janki Solanki |
| Designation |
PG Scholar |
| Affiliation |
Rajkot Homeopathic Medical Collage |
| Address |
Department of Organon of Medicine and Homeopathic Philosophy, Rajkot Homeopathic Medical Collage, Behind Jaynath complex, Makkam chowk, Rajkot
Rajkot
GUJARAT
360002
India |
| Phone |
9712934431 |
| Fax |
|
| Email |
drjankisolanki89@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saunil Malvania |
| Designation |
professor |
| Affiliation |
Rajkot Homeopathic Medical collage |
| Address |
Department of Organon of Medicine & Homeopathic Philosophy
Rajkot Homeopathic Medical Collage
Behind Jaynath Complex
Makkam chowk
Gondal road
Rajkot
Rajkot
GUJARAT
360002
India |
| Phone |
9825416487 |
| Fax |
|
| Email |
saunil.malvania23663@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saunil Malvania |
| Designation |
professor |
| Affiliation |
Rajkot Homeopathic Medical collage |
| Address |
Department of Organon of Medicine & Homeopathic Philosophy
Rajkot Homeopathic Medical Collage
Behind Jaynath Complex
Makkam chowk
Gondal road
Rajkot
Rajkot
GUJARAT
360002
India |
| Phone |
9825416487 |
| Fax |
|
| Email |
saunil.malvania23663@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Rajkot Homeopathic Medical Collage
Behind Jaynath complex
Makkam chowk
Gondal road
Rajkot - 360002
Gujarat
India |
|
|
Primary Sponsor
|
| Name |
Rajkot Homeopathic Medical Collage |
| Address |
Rajkot Homeopathic Medical Collage
Behind Jaynath complex
Makkam chowk
Gondal road
Rajkot - 360002
Gujarat |
| Type of Sponsor |
Private medical college |
|
|
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 Janki Solanki |
Rajkot Homeopathic Medical Collage |
Department of Organon of Medicine and Homeopathic Philosophy, Rajkot Homeopathic Medical Collage,
Behind Jaynath complex,
Makkam chowk,
Gondal road,
Rajkot
Rajkot
GUJARAT |
9712934431
drjankisolanki89@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Human Research - Rajkot Homeopathic Medical Collage (RHMC) Parul University Rajkot Gujarat |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K649||Unspecified hemorrhoids, (2) ICD-10 Condition: K640||First degree hemorrhoids, (3) ICD-10 Condition: K641||Second degree hemorrhoids, (4) ICD-10 Condition: K648||Other hemorrhoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised homeopathic medicine on the base of miasmatic understanding |
Individualised homeopathic medicine selected on base of miasmatic understanding in cases of haemorrhoids.
Mode of administration: Oral (Sublingual).
Selection of dosage, potency & repetition: individualised homeopathic medicine will be prescribe in 30, 200, 1M potency. Selection of dosage, potency & repetition will be according to susceptibility of patient and principles of prescription given in Organon of Medicine and Homeopathic Philosophy.
Total duration of study: 9 months |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient both gender.
Cases of age group between 18 to 65 years.
Diagnostic criteria are mainly based on the clinical examination. |
|
| ExclusionCriteria |
| Details |
Cases of age below 18 and 65 years.
Patients with other severe systemic disorders.
Patients with severe haemorrhage with very low HB.
Patients having 3rd and 4th degree haemorrhoids.
patients having fissure in ano, fistula in ano, anorectal abscess, rectal carcinoma, rectal prolapse and other diseases having rectal complaint as secondary phenomena. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Subjective clinical improvement with reduction of complaints and restoration of health after prescribing individualised homeopathic medicine on basis of miasmatic dominance. |
After the intervention, first follow up will be done every 15 days. Followed by subsequent follow ups. There will be noticeable improvement after prescribing individualised homeopathic medicine. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To analyse all the cases of haemorrhoids on basis of miasmatic background & totality of symptoms.
To match the patient’s totality of symptoms with the totality of drugs including the miasmatic presentation.
To improve the quality of life in the patients suffering from haemorrhoids. |
It will be obtained within the time frame of primary outcome i.e. within 9 months of period. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
25/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/06/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Haemorrhoids remain the most common anorectal disorder which is frequently seen in primary care clinics, gastroenterology units and surgical clinics. Haemorrhoids are dilated plexus of superior haemorrhoidal veins in relation to anal canal, it may be internal or external depending on position of varicosities. Haemorrhoids are usually not a serious medical condition and can be managed with conservative measures such as dietary changes and lifestyle modification, however some severe cases may require medications and medical procedures. Now a days, many physician sees a great number of patients who suffer from problems associated with venus insufficiency, haemorrhoids are one of them. Worldwide, the prevalence of symptomatic haemorrhoid is estimated 4.4 percent with the highest prevalence in those between 45 to 65 years of age. According to summary of the association of colon and rectal surgeons of India, about 50 percent of the population would have haemorrhoids at some point in the life probably by the time they reach at the age of 50. It is estimated that one third of India’s population will suffer from haemorrhoids at some stage in their life. Patients presenting with haemorrhoidal disease are more frequently from higher socio-economic status and from rural areas. One of the leading cause is pregnancy that predispose woman to developing symptomatic haemorrhoids. There are number of causes like low fiber diet, straining during defecation, prolonged standing posture, weakness of connective tissue, over purgation, chronic diarrhoea, constipation, and hereditary factors, although often the exact cause is unknown. In contemporary management system of medicine, physician follows some treatment procedures, such as haemorrhoidal artery ligation, sclerotherapy, cryosurgery, infrared coagulation, barrons band application, cauterisation and stapled haemorrhoidopexy, which can affect daily routine of an individual and can hinder persons ability to work, this treatment of haemorrhoid treat the condition at one point of time, but does not give an assurance about recurrence. With its holistic approach, homoeopathic system of medicine offers not only relief but annihilate the disease in its whole extent, in most shortest, most reliable and most harmless way, especially when the disease is reversible, Irreversible changes can only be managed. It also eliminate the chances of complication and possibility of surgery. moreover, thorough homeopathic treatment can remove the tendency and prevent its recurrence. Haemorrhoids are considered pure surgical disorder according to allopathic system of medicine, but in homoeopathy, according to Dr Hahnemann, it is a true natural chronic disease that arises from chronic miasm, an invisible polluting substance, which once gains entrance over powers vital force and produces tendencies for particular diseases. Understanding the miasmatic background of a patient is believed to help prescribe medicines that address the individual’s underlying state of health. If the disease is left unchecked and maltreated in its initial stage when reversible changes are there, it goes deeper and go on increasing and worsening the condition with irreversible structural changes of patients with ever aggravated suffering, which may progress towards the surgical intervention. |