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CTRI Number  CTRI/2024/06/068759 [Registered on: 12/06/2024] Trial Registered Prospectively
Last Modified On: 11/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Chronic constipation in old age - Homeopathy  
Scientific Title of Study   An Experimental study to Ascertain the Effectiveness of Individualized Homeopathic Medicines in Cases of Chronic Constipation in Geriatric.  
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 Mohit Ashokkumar Nanani  
Designation  PG Scholar 
Affiliation  Rajkot Homeopathic Medical College 
Address  Department Of Practice Of Medicine, Rajkot Homeopathic Medical College, Behind Jainath Complex, Makkam Chowk, Gondal road, Rajkot-360002, Gujarat, India

Rajkot
GUJARAT
360002
India 
Phone  9376136556  
Fax    
Email  nananimohit@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Hitarth N. Mehta. 
Designation  HOD/ Professor  
Affiliation  Rajkot Homeopathic Medical College 
Address  Department of Practice of Medicine, Rajkot Homeopathic Medical College, behind jainath Complex, makkam chowk, Gondal road, Rajkot-360002, Gujarat, India

Rajkot
GUJARAT
360002
India 
Phone  9825340073  
Fax    
Email  hitarth.mehtarhmc@paruluniversity.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Mohit Ashokkumar Nanani  
Designation  PG Scholar 
Affiliation  Rajkot Homeopathic Medical College 
Address  Department Of Practice Of Medicine, Rajkot Homeopathic Medical College, behind jainath complex, makkam chowk, Gondal road, Rajkot-360002, Gujarat, India

Rajkot
GUJARAT
360002
India 
Phone  9376136556  
Fax    
Email  nananimohit@gmail.com  
 
Source of Monetary or Material Support  
Rajkot Homeopathic Medical College, Beside Jainath Complex, Makkam Chowk, Gondal road, Rajkot-360002, Gujarat, India 
 
Primary Sponsor  
Name  Rajkot Homeopathic medical college 
Address  Behind Jainath complex, Makkam Chowk, Gondal Road, Rajkot-360002, Gujarat, India 
Type of Sponsor  Private medical college 
 
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 Mohit Nanani  Sainath Homeopathic Medical Hospital attached with Rajkot Homeopathic Medical College.  Department of Practice of Medicine, Rajkot Homeopathic Medical college, Behind Jainath complex, Makkam Chowk, Gondal road, Rajkot-360002, Gujarat, India
Rajkot
GUJARAT 		 9376136556
-
nananimohit@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 College(RHMC), Parul University, Gujarat  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K00-K95||Diseases of the digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  N/A  N/A 
Intervention  Various Individualised Homoeopathic Medicine  Various Individualised Homoeopathic medicine is selected for every case. Mode of Administration: oral(Sublingual). After Administration of medicine condition of the patient will be assed after every two weeks for the further modification in patient. And final assesement will be done after five months Selection of potency, dose and repetition: Various Individualised Homeoeopathic medicine will be prescribed in 30,200 and 1M Potencies through oral (sublingual route), which is selected according to Susceptibility Of Patient and Principle of Organon of Medicine. Dose and Repetition of the Medicine will also be selected according to principles of Organon of Medicine.  
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Cases Diagnosed With ROME IV Criteria for functional Constipation are Included
Cases of Chronic Idiopathic Constipation are Included. 
 
ExclusionCriteria 
Details  Cases below 65 years of Age are excluded.
Cases of organic and mechanical constipation are excluded.
Cases of secondary Constipation are excluded.
Cases of Acute Onset Constipation  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Patients of Chronic Constipation in geriatrics will be benefitted by Individualized Homeopathic Medicines   Patients of Chronic Constipation in geriatrics will be benefitted by Individualized Homeopathic Medicines- This Outcome will be achieved in period of 9 months.  
 
Secondary Outcome  
Outcome  TimePoints 
According to Cleveland clinical constipation score, Significant Improvement- sense of well being with no complaints & relapse of symptoms.
Moderate Improvement: Relieved from presenting complaints in frequency & intensity.
Mild Improvement: When there is only slight improvement in intensity of Symptoms.
No Improvement: When there is neither increase or decrease in intensity of Symptom.
no improvement  		 According to Cleveland clinical constipation score, Significant Improvement- sense of well being with no complaints & relapse of symptoms.
Moderate Improvement: Relieved from presenting complaints in frequency & intensity.
Mild Improvement: When there is only slight improvement in intensity of Symptoms.
No Improvement: When there is neither increase or decrease in intensity of Symptom.
This Goals will be achieved in the period of 9 months  
 
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   Phase 2 
Date of First Enrollment (India)   22/06/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

“Constipation can make you realize that life is not easy”- Rubal Bhatia

 

           Chronic constipation is being an eternal enigma in the gastroenterological practice globally along with India. Studies on Indians have shown that, frequency of stool 14times/week are considered as normal and majority of stool were of Bristol type IV. Stool frequency decreases with age (>35years) with sedentary lifestyles in which people of old age especially females are more affected. Definition of constipation varies in different population on various factors.  The factors affecting constipation are bowel habits, dietary habits, lifestyles, fluid intake and differences in gut transit time respectively.[1]

           According to Global study of ROME Foundation 2021, More than 40% of people worldwide have functional gastrointestinal disorders and their quality of life is affected.[2] Global prevalence of chronic constipation was noted to be 14% according to meta-analytical study carried out on 45 different communities. According to Indian Motility and Functional Diseases Association and the Indian Society of Gastroenterology, A multicentric study of 22 different communities all over India had taken place, in which 53% people have self-perceived constipation.[3]

          Studies have shown that Health related Quality of life is affected due to chronic constipation in old age.[4] Chronic constipation disturbs daily life making the person low spirited, prone to insomnia, anxiety and depression. Due to difficulty in defecation, blood pressure, and myocardial oxygen consumption is increased leading to aggravation of Myocardial Infarction and Cerebral hemorrhage. Also, exertion of pressure on rectum leads to rectal prolapse, hemorrhoids, hernia, ischemic colitis. Colonic Obstruction and urinary retention or infection occurs due to accumulation of hard feces and sometimes intestinal perforation can also occur. Due to thinning of wall of intestine in old age, Chronic constipation may lead to diverticulitis. In Many cases, risk of colon cancer is increased.[5]     

          Certain medications can cause or trigger the constipation in old age as an Adverse effect of drugs, such as anti-analgesic, Anti-cholinergic, Anti-Parkinson’s drugs, Anticonvulsant, Anti-depressant, Antidiarrheal, anti-emetic, Anti-histaminic, Antihypertensive drugs.[6] Global Studies have shown that majority of patient taking laxatives for chronic constipation are dissatisfied with laxatives and looking for the alternative medicine.[7] Homeopathy is a Holistic system of science based on the concept of individualization and can be helpful in cases of chronic constipation in old age. The true natural chronic disease are those that arise from chronic miasm, which is one of the fundamental cause of disease. Homoeopathy believes in treating this Fundamental cause of the disease. Thus, Homeopathic medicines can be used for the long-term care for constipation in old age and improve the quality of life of old age. 
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