| CTRI Number |
CTRI/2024/05/067434 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
14/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
TO STUDY THE CORRELATION BETWEEN PRAKRITI AND ARTAV KSHAYA WITH SPECIAL REFERENCE TO OLIGOMENORRHEA |
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Scientific Title of Study
|
Observational Study Of Correlation Between Prakriti And Artav Kshaya With Special Reference To Oligomenorrhea |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pratiksha Ramesh Wable |
| Designation |
PG Scholar |
| Affiliation |
YAC Post Graduation Training & Research Centre Kodoli,Tal-Panhala,Dist-Kolhapur,416114 |
| Address |
2nd Floor,Kriya Sharir Department A/P Yashwant Ayurvedic College Post Graduation Training & Research Centre,kodoli, Tal-Panhala,Dist-Kolhapur,416114
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9370898808 |
| Fax |
|
| Email |
pratiksharameshwable98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satish B Patil |
| Designation |
M.D. Ph.D (Scholar) |
| Affiliation |
YAC Post Graduation Training & Research Centre Kodoli,Tal-Panhala,Dist-Kolhapur,416114 |
| Address |
Second floor,Kriya Sharir Department A/P Yashwant Ayurvedic College Post Graduation Training & Research Centre,kodoli, Tal-Panhala,Dist-Kolhapur,416114
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9765754037 |
| Fax |
|
| Email |
anusatish37@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pratiksha Ramesh Wable |
| Designation |
PG Scholar |
| Affiliation |
YAC Post Graduation Training & Research Centre Kodoli,Tal-Panhala,Dist-Kolhapur,416114 |
| Address |
Second Floor,kriya Sharir Department A/P Yashwant Ayurvedic College Post Graduation Training & Research Centre,kodoli, Tal-Panhala,Dist-Kolhapur,416114
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9370898808 |
| Fax |
|
| Email |
pratiksharameshwable98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Second Floor Department Of kriya Sharir,Yashwant Ayurvedic College Post Graduation Training And Research Centre,Kodoli,Tal-Panhala,Dist-Kolhapur,Maharashtra,India,Pin-416114 |
|
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Primary Sponsor
|
| Name |
Pratiksha Ramesh Wable |
| Address |
A/P Yashwant Ayurvedic College Kodoli,Tal-Panhala,Dist-Kolhapur 416114 |
| Type of Sponsor |
Other [Principal Investigator 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 Pratiksha Ramesh Wable |
Yashwant Ayurvedic College kodoli kolhapur |
Second Floor Department Of Kriya Sharir Yashwant Ayurvedic College kodoli kolhapur
Kolhapur
MAHARASHTRA |
9370898808
pratiksharameshwable98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yashwant Ayurvedic college kodoli kolhapur |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N00-N99||Diseases of the genitourinary system. Ayurveda Condition: ARTAVAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
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Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
female subjects irrespective of caste income group and other occupation will be selected
intermenstural duration more than 35 days
both married and unmarried
oligomenorrhea with normal blood flow
oligomenorrhea with scanty blood flow
|
|
| ExclusionCriteria |
| Details |
subject having other systemic pathology(TB,DM,HIV,HbsAg,etc)
severe anemia
lactating mother
subject taking OCP
subject having IUCD
oligomenorrhea with menorrhagia |
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
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Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| To Study The Correlation Between Prakriti And Artav Kshaya With Special Reference To Oligomenorrhea |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To establish the correlation between prakriti & artav kshaya with oligomenorrhea with the help of ayurvedic text criteria,modern text criteria & laboratorial analysis of heamoglobin report. |
1 day |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/06/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
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 an observation study to study the correlation between prakriti and artav kshaya with special reference to oligomenorrhea.
Ayurveda is an ancient system of medicine documented and practiced in India since time immemorial.According to this system,an individuals Prakriti to a large extent determines predisposition and prognosis to disease as well as therapy and lifestyle regime.
The dosha predominant at the time of conception forms that particular prakriti.This displays the characteristic features which are inherited features which are inherited by an individual during shukrashonitsmyog with influence of the predominant dosha at that time.
In the event of deficiency or loss of artav,the menstruation does not appears in its appropriate timeor in delayed is scanty and does not last 3 days.
In artav kshaya there is also a pain in vagina,this pain is due to aggravation of vayu caused by loss of artav which fills this region.
In oligomenorrhea menstrual bleeding occurring more than 35 days apart and which remains constant at that frequency.
Artav kshaya is vata-kaphatnakvyadhi in which artav chakra of females gets disturbed in terms of Yathochitkaldarshan,Alpata,Yonivedana In modern science it is group of observed in disease of female reproductive system together or separately caused by hormonal imbalance and they are Irregular menstruation,Hypomenorrhea ,Dysmenorrhea So here the word artav kshaya can be compared with oligomenorrhea i.e having symptoms of decreased frequency of menstruation.
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