| CTRI Number |
CTRI/2024/12/077567 [Registered on: 02/12/2024] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to observe the relationship between digestive health and quality of life in individuals with uterine fibroid |
|
Scientific Title of Study
|
An observational study to assess the status of agni and quality of life in uterine fibroid. |
| 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 Rajitha M |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda Collge ,Kannur |
| Address |
Dr Rajitha M
Department of Kriyasareera
Government Ayurveda College ,Pariyaram
Kannur
Kannur
KERALA
670503
India |
| Phone |
8943319385 |
| Fax |
|
| Email |
rajithamraj5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hakkeem Panthappulan |
| Designation |
Assistant Professor |
| Affiliation |
Government Ayurveda College,Pariyaram |
| Address |
Department of Kriyasareera
Government Ayurveda College,Pariyaram
Kannur
KERALA
670503
India |
| Phone |
9947853745 |
| Fax |
|
| Email |
hpanthappulan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajitha M |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda College,Pariyaram |
| Address |
Department of Kriyasareera
Government Ayurveda College
Pariyaram
Kannur
KERALA
670503
India |
| Phone |
8943319385 |
| Fax |
|
| Email |
rajithamraj5@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda Hospital,Pariyaram
Kannur District
pin-670503
India |
|
|
Primary Sponsor
|
| Name |
Dr Rajitha M |
| Address |
Premaraj Bhawan
Kondoorkara
Ongallur
Palakkad
pin -679313 |
| 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 RAJITHA M |
Government Ayurveda College Hospital,Pariyaram |
OPD and IPD OF Prasuti tantra and Streeroga and IPD of all other departments.
Kannur
KERALA |
08943319385
rajithamraj5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Ayurveda College Kannur -Pariyaram P.O Pariyaram Medical College,pin-670503 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D250||Submucous leiomyoma of uterus. Ayurveda Condition: GRANTHIH, (2) ICD-10 Condition:D259||Leiomyoma of uterus, unspecified. Ayurveda Condition: GRANTHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Participants diagnosed with uterine fibroid confirmed by USG in the age group 25 to 45 years visiting OPD and IPD of Government Ayurveda College Kannur
Those who provide informed consent |
|
| ExclusionCriteria |
| Details |
Pregnant women and lactating mother
Subjects with psychiatric illness
Diagnosed case of malignancy and other chronic systemic illness
Those who attained menopause |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Agni score
Quality of life score |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="61"
Sample Size from India="61"
Final Enrollment numbers achieved (Total)= "61"
Final Enrollment numbers achieved (India)="61" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/12/2024 |
| Date of Study Completion (India) |
10/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
10/09/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Uterine fibroids are the most common non-cancerous growths derived from smooth muscle cells of myometrium, affecting 20-40% of women of reproductive age. A variety of risk factors influence both fibroid development and gut homeostasis. In Ayurveda Agni is responsible for a vast range of functions and impaired Agni is the root of all imbalances and diseases.Quality of life is analyzed to know the physical,emotional and social impact of the condition on their overall well being. |