| CTRI Number |
CTRI/2024/01/061570 [Registered on: 18/01/2024] Trial Registered Prospectively |
| Last Modified On: |
21/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study on etiology of and efficacy of lifestyle changes in PCOS. |
|
Scientific Title of Study
|
An interventional study on dietetic etiology (Aharaja nidana) and efficacy of hetu vipareeta ahara in anovulation w.s.r to PCOS. |
| 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 Roopa Dodamani |
| Designation |
Reader |
| Affiliation |
Shri B M Kankanawadi Ayurveda Mahavidyalaya |
| Address |
Dr Roopa Dodamani
Reader
Department of Roganidana
Shri B M Kankanawadi Ayurveda Mahavidyalaya
Shahapur
Belgaum
Belgaum KARNATAKA 590003 India |
| Phone |
9008310851 |
| Fax |
|
| Email |
roopad@kleayurworld.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Roopa Dodamani |
| Designation |
Reader |
| Affiliation |
Shri B M Kankanawadi Ayurveda Mahavidyalaya |
| Address |
Dr Roopa Dodamani
Reader
Department of Roganidana
Shri B M Kankanawadi Ayurveda Mahavidyalaya
Shahapur
Belgaum
Belgaum KARNATAKA 590003 India |
| Phone |
9008310851 |
| Fax |
|
| Email |
roopad@kleayurworld.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Roopa Dodamani |
| Designation |
Reader |
| Affiliation |
Shri B M Kankanawadi Ayurveda Mahavidyalaya |
| Address |
Dr Roopa Dodamani
Reader
Department of Roganidana
Shri B M Kankanawadi Ayurveda Mahavidyalaya
Shahapur
Belgaum
Belgaum KARNATAKA 590003 India |
| Phone |
9008310851 |
| Fax |
|
| Email |
roopad@kleayurworld.edu.in |
|
|
Source of Monetary or Material Support
|
| Shri B M Kankanawadi Ayurveda Mahavidyalaya and Hospital
Shahapur
Belgaum 590003 |
|
|
Primary Sponsor
|
| Name |
KLE Academy of Higher Education and Research |
| Address |
KLE Academy of Higher Education and Research
JNMC Campus
Nehru Nagar
Belgaum 590010 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Shri B M Kankanawadi Ayurveda Mahavidyalaya |
Shri B M Kankanawadi Ayurveda Mahavidyalaya
Shahapur
Belgaum 590003 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Roopa Dodamani |
Shri B M Kankanawadi Ayurveda Hospital |
Shri B M Kankanawadi Ayurveda Mahavidyalaya and Hospital
Endocrinology
3rd Division (Speciality OPD)
Shahapur
Belgaum 590003 Belgaum KARNATAKA |
9008310851
roopad@kleayurworld.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Research on Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N915||Oligomenorrhea, unspecified. Ayurveda Condition: VANDHYA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:yes, Pathya:Protein rich foods
, Apathya:Carbohydrate rich food |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1) Oliguria or Amenorrhea
2) Infertility
3) Weight gain
4) Acne vulgaris
5) Skin thickening and darkening at the nape of neck and inner thighs
•Hirsutism
|
|
| ExclusionCriteria |
| Details |
1) Any other systemic disorders like nutritional deficiency anemia, hepato-biliary diseases, cardiac diseases, pulmonary diseases etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of Protein rich diet in inducing menstruation. |
12 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of Causes & Risk factors for PCOS in terms of Food |
12 Weeks |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
27/01/2024 |
| 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="10" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [roopad@kleayurworld.edu.in].
- For how long will this data be available start date provided 23-12-2024 and end date provided 23-12-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
|
Amenorrhea in PCOS is failure of
maturation and release of ovum into the uterine cavity and it is the major
diagnostic and must appear abnormality in PCOS patients.
Amenorrhea is resulted by
abnormal hormonal secretions during menstruation cycle and can be co related
to vandya yoni vyapat. Generally, in concern of etiology of anovulation we
always talk about life style, environment, genes and organ dysfunction which
interfere the ovulation process and we talk less about dietetic causes of
Anovulation. Improper diet pattern is one among the prime life style issues.
Mithya aachara is term coined for this improper life style in ayurveda
science which even includes improper diet practices (Mithya Ahara).
Most of the women struggles to
maintain fitness and nutrition due to unawareness about what to eat? Or how
to eat? and always live a stressful life to complete their responsibilities
whether she is student or house wife or laborer or professional.
So, in this study we are trying
to rule out that which type of meals and diet pattern is mainly affecting the
ovulation hormones majorly and resulting into anovulation.
This study will be intended to
establish a chart Mithya ahara which are majorly causing Vandya yonivayapat
or Anovulation and how hetu vipareeta aahara reverse the anovulation and
regularize the ovulation in selected population.
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