| CTRI Number |
CTRI/2024/03/064034 [Registered on: 12/03/2024] Trial Registered Prospectively |
| Last Modified On: |
12/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study to determine the efficacy of nutritional modaka in oligomenorrhea. |
|
Scientific Title of Study
|
A single arm interventional study to determine the effectiveness of daily consumption of modaka prepared with krishna tila, marayoor jaggery and trikatu in subjects diagnosed with arthava kshaya |
| 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 Indu V L |
| Designation |
Professor and head, Department of Rasasastra and Bhaishajya kalpana |
| Affiliation |
Kerala University Of Health Sciences |
| Address |
First floor , Room No: 6
Sree Narayana Institute of Ayurvedic Studies and Research, Puthoor, Kollam -691513 Kerala
First floor , Room No: 6
Sree Narayana Institute of Ayurvedic Studies and Research, Puthoor, Kollam -691513 Kerala
Kollam
KERALA
691513
India |
| Phone |
9447156997 |
| Fax |
|
| Email |
drindupradeep@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrIndu V L |
| Designation |
Professor and Head of Department (RASASASTRA AND BHAISHAJYA KALAPANA) |
| Affiliation |
Kerala University Of Health Sciences |
| Address |
First floor , Room No: 6 , Sree Narayana Institute of Ayurvedic Studies and Research, Puthoor, Kollam -691513 Kerala
First floor , Room No: 6 , Sree Narayana Institute of Ayurvedic Studies and Research, Puthoor, Kollam -691513 Kerala
Kollam
KERALA
691513
India |
| Phone |
9447156997 |
| Fax |
|
| Email |
drindupradeep@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sruthi L Unnithan |
| Designation |
Second professional BAMS senior student |
| Affiliation |
Kerala University Of Health Sciences |
| Address |
Rajesh Bhavan, Vattekkunnam Edappally North P.O Kochi - 24
First floor ,Sree Narayana Institute of Ayurvedic Studies and Research, Puthoor, Kollam -691513 Kerala
Kollam
KERALA
682024
India |
| Phone |
8590578429 |
| Fax |
|
| Email |
sruthi2k2aspire@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sree narayana institute of ayurvedic studies and research, Puthoor, Kollam. Pin-691513, KERALA |
|
|
Primary Sponsor
|
| Name |
Sree Narayana Institute of Ayurvedic Studies and Research |
| Address |
Sree Narayana Institute of Ayurvedic Studies and Research, Puthoor, Kollam - 691513 Kerala |
| 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 INDU V L |
SREE NARAYANA INSTITUTE OF AYURVEDIC STUDIES AND RESEARCH |
Department of Kaya chikitsa, Room number – 8, Sree Narayana Institute of Ayurvedic Studies and Research Hospital, Puthoor, Kollam-691513 KERALA
Kollam
KERALA |
9447156997
drindupradeep@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sree Narayana Institute of Ayurvedic Studies and Research-Institutional Ethical Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N915||Oligomenorrhea, unspecified. Ayurveda Condition: ARTAVAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Tila modaka, Reference: NA, Route: Oral, Dosage Form: Modaka, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 8 Weeks, anupAna/sahapAna: No, Additional Information: Tila modaka is prepared with trikatu and marayoor jaggery |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
Girls who are having irregular lengthy menstrual cycles along with painful scanty bleeding and those who have given consent will be recruited into the study. |
|
| ExclusionCriteria |
| Details |
Girls who are having thyroid dysfunction, pituitary dysfunction , adrenal gland dysfunction and those who are undergoing infertility treatment will be excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 50% reduction in pain scale |
base line - initial menstrual pain scale assessment
4 weeks - expected to reduce by 25%
8 weeks - expected to reduce by 50% |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Regular menstrual cycle |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 3 |
|
Date of First Enrollment (India)
|
25/03/2024 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Menstrual
abnormalities are quiet common in adolescent age . This leads to emotional
stress to the adolescent girls. According
to recent statistics, 75% of girls are
experiencing problems associated with menstruation. The major abnormalities are
dysmenorrhea, premenstrual syndrome (PMS), and menstrual irregularities. These disorders may lead to problems in daily
activities such as academic excellence, achievements in sports, and loss of
self-confidence. Present study aims to determine the effectiveness of daily
consumption of modaka prepared with krishna tila, marayoor jaggery and trikatu
in subjects diagnosed with oligomenorrhea or artava kshaya. This study is an
open labelled single arm clinical trial. Primary outcome will be reduction in
lengthy cycles and painful bleeding.
|