| CTRI Number |
CTRI/2026/03/106181 [Registered on: 13/03/2026] Trial Registered Prospectively |
| Last Modified On: |
13/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Homoeopathic Treatment on Constipation in Women with Anxiety |
|
Scientific Title of Study
|
Cohort study of constitutional homoeopathic management in constipation with selected patients of anxiety disorder in female |
| 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 Nandini Shekharrao Papde |
| Designation |
PG Scholar |
| Affiliation |
Sonajirao Kshirsagar Homoeopathic Medical College Beed |
| Address |
Department of Organon and Homoeopathic Philosophy, Division
Homoeopathy, Room no 3, Sonajirao Kshirsagar Homoeopathic
Medical College, Beed, Maharashtra
Bid
MAHARASHTRA
431122
India |
| Phone |
7499803479 |
| Fax |
|
| Email |
nandinipapde@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Vasant Shah |
| Designation |
Professor and Guide |
| Affiliation |
Sonajirao Kshirsagar Homoeopathic Medical College Beed |
| Address |
Department of Organon and Homoeopathic Philosophy, Division
Homoeopathy, Room no 3, Sonajirao Kshirsagar Homoeopathic
Medical College, Beed, Maharashtra
Bid
MAHARASHTRA
431122
India |
| Phone |
9422241390 |
| Fax |
|
| Email |
deepakshah.perfect@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nandini Shekharrao Papde |
| Designation |
PG Scholar |
| Affiliation |
Sonajirao Kshirsagar Homoeopathic Medical College Beed |
| Address |
Department of Organon and Homoeopathic Philosophy, Division
Homoeopathy, Room no 3, Sonajirao Kshirsagar Homoeopathic
Medical College, Beed, Maharashtra
Bid
MAHARASHTRA
431122
India |
| Phone |
7499803479 |
| Fax |
|
| Email |
nandinipapde@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sonajirao Kshirsagar Homoeopathic Medical College, Vidyanagar West,Beed 431122 |
|
|
Primary Sponsor
|
| Name |
Dr Nandini Shekharrao Papde |
| Address |
Sonajirao Kshirsagar Homoeopathic Medical College Vidyanagar West Beed 431122 |
| Type of Sponsor |
Other [Self Sponsered ] |
|
|
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 Nandini Shekharrao Papde |
Sonajirao Kshirsagar Homoeopathic Medical College And Hospital Beed |
Department Of Organon And Homoeopathic Philosophy, Division Homoeopathy Room No 3, Sonajirao Kshirsagar Homoeopathic Medical College Beed
Bid
MAHARASHTRA |
7499803479
nandinipapde@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sonajirao Kshirsagar Homoeopathic Medical College And Hospital Beed |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K590||Constipation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Cases presenting with various and characteristic
symptoms , modalities in constipation with
diagnosed anxiety disorder in female will be
included in my study.
Subject between 18 years to 60years of age were
included in the study.
Recurrent constipation at least 3 days per week
in the last three months.
Pain or discomfort related to defaecation , a
change in stool frequency or a change in stool form
or appearance |
|
| ExclusionCriteria |
| Details |
Patient who require emergency medical
treatment.
Ruling out other medical conditions that
might be causing similar symptoms.
Medication induced constipation
Inability to give informed consent. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Bristol Stool Scale
Hamilton Anxiety Rating Scale |
Outcome Assessment Will Be Done Only at Prestudy (baseline) and pPoststudy Will Be Done At The End of 3 Months
Follow up Visits Will Be Conducted Every Month During This Period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NOT APPLICABLE |
NOT APPLICABLE |
|
|
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)
|
24/03/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This is a Prospective Cohort Study Designed to Evaluate the Effectiveness of Individualized Homoeopathic Medicines for Constipation in females of 18 to 60 years Age Group having Anxiety Disorder By Using Bristol Stool Scale and Hamilton Anxiety Rating Scale This Study wil be undertaken for 1 year and 6 months Sample Size will be 44 and Outcome Assessment Will Be Done Prestudy And Post Study after 3 months After data collection data will be analysed and evaluated with appropriate statistical test |