| CTRI Number |
CTRI/2025/03/082756 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational |
| Study Design |
Other |
|
Public Title of Study
|
A study to observe the role of Body Tissue Health and Lower Abdominal Function in Menstrual Disorders |
|
Scientific Title of Study
|
An observational study to assess dhatusarata and status of apana vayu in artavakshaya |
| 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 Aswathy L |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda College,Pariyaram,Kannur |
| Address |
Department of Kriyasareera
Government Ayurveda College,Pariyaram,Kannur
Kannur
KERALA
670503
India |
| Phone |
09544429268 |
| Fax |
|
| Email |
lijiniaswathy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep K |
| Designation |
Professor |
| Affiliation |
Government Ayurveda College,Pariyaram,Kannur |
| Address |
Department of Kriyasareera
Government Ayurveda College,Pariyaram,Kannur
Kerala
670503
India
Department of Kriyasareera
Government Ayurveda College,Pariyaram,Kannur
Kerala
670503
India
Kannur
KERALA
670503
India |
| Phone |
9846606351 |
| Fax |
|
| Email |
drpradeep601@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep K |
| Designation |
Professor |
| Affiliation |
Government Ayurveda College,Pariyaram,Kannur |
| Address |
Department of Kriyasareera
Government Ayurveda College,Pariyaram,Kannur
Kerala
670503
India
Department of Kriyasareera
Government Ayurveda College,Pariyaram,Kannur
Kerala
670503
India
KERALA
670503
India |
| Phone |
9846606351 |
| Fax |
|
| Email |
drpradeep601@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda Hospital,Pariyaram,Kannur,670503 |
|
|
Primary Sponsor
|
| Name |
Dr Aswathy L |
| Address |
Department of Kriyasareera
Government Ayurveda College
Pariyaram
Kannur
670503 |
| 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 |
| Aswathy L |
Government Ayurveda College Hospital,Pariyaram |
OPD and IPD of Prasutitantra and Streeroga Department
Kannur
KERALA |
09544429268
lijiniaswathy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee Government Ayurveda College,Kannur,Pariyaram,670503 |
Approved |
|
|
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 |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Oligomenorrhea-Menstrual bleeding occurring more than 35 days apart and which remains constant at that frequency.
Hypomenorrhea-Menstrual bleeding, unduly scanty and lasts for less than 2 days. |
|
| ExclusionCriteria |
| Details |
Concurrent or previous usage of oral contraceptive pills within a period of last 6 months
Lactating women
Pregnancy
Subjects diagnosed with psychiatric illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Dhatusarata Score
Apana vayu Score |
18 Months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
31/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
31/03/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
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
|
Artavakshaya has been described by
Acharya Sushruta, which is the deficiency of artava and it can be correlated with
Oligomenorrhea and Hypomenorrhea. Oligomenorrhea is menstrual bleeding occurring more
than 35 days apart. When the menstrual bleeding is unduly scanty and lasts for less than 2 days
it is called Hypomenorrhea.Previous study shows the prevalence of menstrual disorders as 85-93.4% in
India. Since Artava is the upadhatu of Rasa dhatu, in Artavakshaya, Dhatusarapareeksha can
be used to determine the qualitative excellence of each dhatu. By assessing the status of Apana
vayu and its derangement, literary hints of Apana vayu, explained in Kriyasareera can be
validated and adequate management can be designed in Artavakshaya. Sarapareeksha is one of the ten methods to examine a patient. Apana vayu, one among the five divisions of Vata, is responsible for the proper expulsion of artava.In this study, subjects are selected from OPD and IPD of W & C Hospital, GAVC, Pariyaram, Kannur, and their Dhatusarata is evaluated by Sarapareeksha proforma prepared by AYU SOFT CDAC. The status of Apana vayu will be assessed using a questionnaire prepared by Dr Anju Aravind T et al.By understanding the Dhatusarata, and the status of Apana vayu in Artavakshaya, the line of treatment can be decided accordingly. Assessment of the status
of Apana vayu and Dhatusarata, the knowledge helps to improve the treatment methods and
thereby the quality of life in Artavakshaya.
|