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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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N915||Oligomenorrhea, unspecified. Ayurveda Condition: VANDHYA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmLifestyle--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
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [roopad@kleayurworld.edu.in].

  6. 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.

  7. 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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