| CTRI Number |
CTRI/2025/03/082529 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive
Screening |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Study of Yava Diet and Shatapushpa yoga in Painful periods. |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY OF DIET PROTOCOL BASED ON YAVA ANNA AND SHATAPUSHPA YOGA IN THE MANAGEMENT OF KASHTARTAVA(PRIMARY DYSMENORRHEA) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
BHANU PRIYA |
| Designation |
MD SCHOLAR |
| Affiliation |
National Institute of Ayurveda |
| Address |
National Institute of Ayurveda, Deemed to be University Jorawar Singh Gate , Amer Road , jaipur , rajasthan , India
Jaipur
RAJASTHAN
302002
India |
| Phone |
8764052803 |
| Fax |
|
| Email |
bhanupriya8090@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Krutika Chaudhary |
| Designation |
BAMS , MD , Ph. D. Assistant Professor (Senior) |
| Affiliation |
National Institute of Ayurveda |
| Address |
Room No. 135 Dravyaguna Deaprtment , National Institute of Ayurveda, Deemed to be University Jorawar Singh Gate , Amer Road , jaipur , rajasthan , India
Jaipur
RAJASTHAN
302002
India |
| Phone |
9408648068 |
| Fax |
|
| Email |
vd.krutika@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
BHANU PRIYA |
| Designation |
MD SCHOLAR |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Dravyaguna Room no. 137 , National Institute of Ayurveda, Deemed to be University Jorawar Singh Gate , Amer Road , jaipur , rajasthan , India
Jaipur
RAJASTHAN
302002
India |
| Phone |
8764052803 |
| Fax |
|
| Email |
bhanupriya8090@gmail.com |
|
|
Source of Monetary or Material Support
|
| NATIONAL INSTITUTE OF AYURVEDA |
|
|
Primary Sponsor
|
| Name |
NATIONAL INSTITUTE OF AYURVEDA |
| Address |
National Institute of Ayurveda , Deemed To Be University (De-novo), Jorawar Singh Gate , Amer Road , Jaipur(Raj.)-302002 |
| Type of Sponsor |
Government 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 |
| Bhanu Priya |
NATIONAL INSTITUTE OF AYURVEDA |
OPD No. 26, 27 National Institute of Ayurveda Deemed to be University(De-novo), Jorawar Singh Gate , Ajmer Road , Jaipur (Raj.)
Jaipur
RAJASTHAN |
8764052803
bhanupriya8090@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE NATIONAL INSTITUTE OF AYURVEDA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N944||Primary dysmenorrhea. Ayurveda Condition: ARTAVADOSHAH/ARTAVADUSHTIH/RAJODOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Rajaswala charya - havishya anna as per yagnyavalak, Pathya/Apathya:yes, Pathya:yava,godhum,moonga,maricha,hingu,sunthi,saindhav,ksheera, ghritta, Apathya: | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shatapushpa yoga, Reference: Kashyap samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 3 Days, anupAna/sahapAna: Yes(details: -goghritta), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
Subjects having kashtartava since 2 Months having VAS Scale range from 1 to 5
(mild to moderate pain). |
|
| ExclusionCriteria |
| Details |
Subjects K/C/O suffering from venerealdiseases, systemicdiseases, coagulation
disorders, Any type of malignancy, congenital and structural abnormality of
uterus.
Subjects with H/O hypothyroidism and hyperthyroidism. Subject planning to conceive . Subjects using intra uterine contraceptive devices. Patients taking OCPs .Haemoglobin less than 9 gm%. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in the VAS Scale. |
Improvement in the VAS Scale& VMSS Scalesymptoms of
kashtartava(Primary dysmennorhea)within 3 subsequent cycle. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| VMSS Scale: Verbal Multidimensional Scoring System |
At baseline and end of 60 days treatment |
|
|
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 2 |
|
Date of First Enrollment (India)
|
23/03/2025 |
| 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="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
|
Kasthartava is becoming today’s burning problem throughout the world which causes
discomfort for women’s routine lifestyle and further health. Its considered as a very
common phenomena during menstruation that people ignore the Discomfort, seek
late medical advice, delay its treatment and ultimately land on hazardous conditions like
PCOD, Infertility , Cancer, etc. The symptomatic management advocated in contemporary
medicine(analgesics, antispasmodics, and/or oral contraceptive pills) does not provide a
long-lasting solution and may lead to serious adverse effects.14Thus, there is an urgent
need for clinicians to develop effective preventive, maintenance strategies and treatment
modalities that can be easily available and applicable to women in the community. Modified
diet protocol can be adopted and followed regularly. Havishya anna can easily be prepared but due to lack of proper research on this
particular topic and modification in this field , this topic is selected for the further research
purpose.
Here , yava anna is selected as a part of Havishya anna which is indicated in Kasthartava
by Yajnavalkya Smriti . Havishyam as meal (including Ghee, Sali rice or Yava anna, barley, milk etc ) is to be given
during the Dysmenorrhoea .It is associated with religious practice for better
implementation in regular practice . Yava anna is selected due to its madhur & kashaya rasa
, guru , rukshan , pichila action as it is more appropriate for current sedentary lifestyle.
AIM
To study the efficacy of DietProtocol based on Yava anna andShatapushpa Yoga in the
management of kashtartava (Primary dysmenorrhea).
OBJECTIVES -To develop standard Ayurvedic diet protocol of Rajaswala charya based on yava anna
on kashtartava(Primary dysmenorrhea). To review and analyze the efficacy of yava anna and shatapushpa yoga with special
reference to kashtartava (Primary dysmenorrhea).
Null Hypothesis[H0]- Diet Protocol based on Yava anna andShatapushpa yoga is not
efficacious in the management ofkashtartava (Primary dysmenorrhea).
Alternative Hypothesis [H1] -Diet Protocol based on Yava anna andShatapushpa yoga
is efficacious in the management ofkashtartava (Primary dysmenorrhea).
Study Design :Clinical trial Study Type : Intervention .Phase of clinical trial : II Number of groups : 2 Site of Study: National Institute of Ayurveda,(deemed university)Jaipur. Study Setting : Prasuti and Striroga OPD and IPD NIA DU Jaipur. Study Duration : 18 months |