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CTRI Number  CTRI/2024/03/064743 [Registered on: 26/03/2024] Trial Registered Prospectively
Last Modified On: 22/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Medicated Gruel made from rice (Yavagu) in Painful menstruation. 
Scientific Title of Study   Open Clinical Trial Of Vatanulomini Yavagu In Udavartini Yonivyapad (Dysmenorrhoea) W.S.R To Charak Samhita. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Varsharani Dilip Jathar 
Designation  PG scholar 
Affiliation  Government Ayurved College and Hospital, Nagpur 
Address  Department of Sanskrit Samhita Siddhant, Room no.- 22,23 Government Ayurved College and Hospital, Sakkardara Square, Nagpur Nagpur MAHARASHTRA 440024 India
Department of Sanskrit Samhita Siddhant, room no.-22,23 Government Ayurved College and Hospital, Sakkardara Square, Nagpur Nagpur MAHARASHTRA 440024 India
Nagpur
MAHARASHTRA
440024
India 
Phone  8600581361  
Fax    
Email  jathar2017@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Arun Bhatkar 
Designation  Associate Professor 
Affiliation  Government Ayurved College and Hospital, Nagpur 
Address  Department of Sanskrit Samhita Siddhant, room no.-22,23 Government Ayurved College and Hospital, Sakkardara Square, Nagpur Nagpur MAHARASHTRA
Department of Sanskrit Samhita Siddhant, room no.-22,23 Government Ayurved College and Hospital, Sakkardara Square, Nagpur Nagpur MAHARASHTRA
Nagpur
MAHARASHTRA
440024
India 
Phone  7387249075  
Fax    
Email  arunbhatkar19@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Varsharani Dilip Jathar 
Designation  PG scholar 
Affiliation  Government Ayurved College and Hospital, Nagpur 
Address  Department of Sanskrit Samhita Siddhant, Room no.-22,23 Government Ayurved College and Hospital, Sakkardara Square, Nagpur Nagpur MAHARASHTRA
Department of Sanskrit Samhita Siddhant, Room no.-22,23 Government Ayurved College and Hospital, Sakkardara Square, Nagpur Nagpur MAHARASHTRA
Nagpur
MAHARASHTRA
440024
India 
Phone  8600581361  
Fax    
Email  jathar2017@gmail.com  
 
Source of Monetary or Material Support  
Department of Streerog and Prasutitantra, Opd no.-42, Government Ayurved College and Hospital,Nagpur 
 
Primary Sponsor  
Name  Government Ayurved College and Hospital 
Address  Government Ayurved College and Hospital,sakkardara chowk,Nagpur. 
Type of Sponsor  Other [Government Ayurved College and Hospital] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Varsharani Dilip Jathar  Government Ayurved College and Hospital, Nagpur  Department of Streerog and Prasutitantra, Opd no.-42, Government Ayurved College and Hospital, Sakkardara Square, Nagpur.
Nagpur
MAHARASHTRA 
8600581361

jathar2017@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government Ayurved College Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N946||Dysmenorrhea, unspecified. Ayurveda Condition: UDAVARTINI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Vatanulomini Yavagu, Reference: Acharya Y.T. (ed) Charak Samhita, Ayurved dipika vyakhya, Chakrapanidatta, Sutrasthan Apamargtanduliy adhyay- 2, Verse- 29, Varanasi Chaukhamba Surbharti Prakashan., Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(g), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -Vatanulomini Yavagu will be given for 7 days before menstrual cycle for 3 consecutive cycles
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Female 
Details  1)Unmarried Patients having age between 18
to 30 years
2)Patient fulfilling diagnostic criteria-
patient complaining of Udavartini Yonivyapad
(Dysmenorrhoea)
3)Patients suffering from painful
menstruation for more than 2 consecutive cycles.
4)Patients who gives written consent.
5)Co-operative Patients.
 
 
ExclusionCriteria 
Details  1)Patients of age less than 18 and greater than 30
years.
2)Married patients
3)Patients already diagnosed with or having any
history of other systemic diseases that may
interfere with the course of Treatment
4)Patients taking hormonal therapy.
5)Patients having congenital anomaly of
reproductive track.
6)Patients with any identifiable pelvic pathology.
7)Patient having irregular menses & PCOS.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the efficacy of Vatanulomini Yavagu in Udavartini Yonivyapad (Dysmenorrhoea) in 3 months  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. To study Agnidipak property of Yavagu.
2. To study Udavartini Yonivyapad in details. 
18 months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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/ Phase 3 
Date of First Enrollment (India)   30/03/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Screening of patients will be done after the institutional ethics clearance of Government Ayurved College, Nagpur. 

Udavartini Yonivyapad (Dysmenorrhoea)-affected patients will be screened via pre-assessment criteria based on general signs and symptoms of Udavartini Yonivyapad (Dysmenorrhoea). 

In the clinical study, 40 patients with Udavartini Yonivyapad (dysmenorrhoea) will be included. Assessment of pain will be done according to a multi-dimensional scoring pattern and the VAS scale of pain assessment. 

During the informed consent process, the subjects were given enough time to read the patient information sheet and consent form. 

Subjects will also be given the freedom to ask questions, and all the questions will be answered. If she agrees to participate in the study and is found fit to be included during screening, then she will be recruited for the study. If all inclusion criteria are yes and all exclusion criteria are no, then subjects will be included on the basis of the criteria given.

Background:

Ayurveda is a health science. It’s purpose is to maintain the health of healthy individual and cure the disease of a patient. In Ayurvedic text all Dravya’s are classified into two categories – ‘Aushadha’ and ‘Ahara’. ‘Ahara’ is used for treatment of disease and also for maintaining health. In Ayurveda, ‘Ahara’ (food items) which are used for treatment are named as ‘Pathya Kalpana’. Yavagu is one of the Pathya Kalpana, prepared from basic ingredient – Rice which is easy to digest. Yavagu is Laghu, Agnidipak and gives Anuloman Gati to Vata, Mutra and Purish. In Ayurveda, Acharya Charak has mentioned “Vinshati Yonivyapad” in Chikitsasthan, which reveals most of the gynaecological disorders. Udavartini Yonivyapad is a disease mentioned by Acharya Charak under Vinshati Yonivyapad. Udavartini Yonivyapad is a Vata predominance disease. There is a derangement of Apana Vayu, as it plays a vital role in maintaining the normal function of ‘Raja’ which further leads to Udavartini Yonivyapad, where painful onset of menstruation is relieved after flow. Udavartini Yonivyapad is compared to dysmenorrhea in modern perspective. Dysmenorrhoea means painful menstruation of sufficient magnitude so as to incapacitate day to day activities. The incidence of primary dysmenorrhea of sufficient magnitude with incapacitation is about 15–20 percent. It occurs mainly in young age. It is also more common in women who never had children. The considerable high prevalence of dysmenorrhoea among adolescents verified that this condition is a significant public health problem that requires great attention. In Udavartini Yonivyapad due to forceful evacuation & controlling natural urges, Vata goes in upward direction which leads to painful menstruation. Vatanulomini Yavagu can be used as therapeutic nutrition to treat Udavartini Yonivyapad by giving Vata it’s proper direction. Vatanulomini Yavagu is one of the twenty-eight Yavagu’s mentioned by Acharya Charak in Sutrasthan. This study is carried out with the aim to study the efficacy of Vatanulomini Yavagu in the patients suffering from Udavartini Yonivyapad.

 

Purpose of Trial: 

Menstruation is important from reproduction point of view and also for the general health of women. Any abnormality related to menstruation can affect her general health and bring difficulty in achieving her goals. In Udavartini Yonivyapad there is painful menstruation which disturb her daily routine activities. In modern science analgesics, antispasmodic and surgery are few options for its treatment, but they cause various side effect. However, Vatanulomini Yavagu is one of the Pathya Kalpana having no side effect and it is helpful to give Vata it’s proper direction.

Aim: To evaluate efficacy of Vatanulomini Yavagu in Udavartini Yonivyapad.

 

Medium of Dissertation: The Dissertation will be written in English by using Ayurvedic terminology wherever necessary in Sanskrit.

Type of Study: Open clinical trial with single arm.

Ethical Clearance:  Clearance from IEC of our institute.

Location of study: Research institute, Hospital and periphery.

Duration of study: study will be carried out for 18 months after approval of synopsis.

Study design:

 Review of literature & Selection of topic

                                      |

 Synopsis writing & Institutional Ethics committee approval.

                                      |

 Synopsis submission & approval

                                      |

 Identifying raw drug & their authentication

                                       |

Packaging & Standerdization of Yavagu sachets.

                                       |

Selection of patient as per inclusion & exclusion criteria.

                                        |

 Informed & written consent will be taken.

                                         |

Detailed CRF will be taken & patient will be informed about the dose, time & training of preparation of Vatanulomini Yavagu.

                                         |

 Follow up of patient on 5th day of menses.

                                          |

Observation, data collection & statistical evaluation.  

Discussion & Conclusion

Duration of treatment: Vatanulomini Yavagu will be given for 7 days before menstrual cycle for 3 consecutive cycles.

Drug- Medicated Yavagu of Haritaki, Pippalimula and Vishwabheshaja.

Preparation of Drug:

Step 1- In first step medicated water is prepared with Abhaya(3gm), Pippalimula(3gm), Vishwabheshaja (3gm) in 576 ml water. That is 1:64 proportion (As per Chakrapani tika)  

Step 2- Then Yavagu is made with this medicated water.  Yavagu is prepared with six part of medicated water and one part of coarse powdered rice. Then it is boiled on mild fire till the rice is cooked and a little amount of water is allowed to remain in the final recipe. The additives (i.e Salt ) can be added according to taste before serving.  Patient were advised to consume this Yavagu lukewarm.

Dose â€“ 50 gm (at evening diet) 

Duration of treatment on single volunteer:

Vatanulomini Yavagu will be given for seven days before the first day of menstrual cycle for three consecutive cycles.

Follow up: on 5th day of menses of each menstrual cycle for 3 consecutive cycles.

 

 
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