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CTRI Number  CTRI/2024/08/072919 [Registered on: 22/08/2024] Trial Registered Prospectively
Last Modified On: 20/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of Artavajanan property of JVAS(Jyotishmati,Vacha,Asan,Swarjika kshar)compound in Amenorrhoea 
Scientific Title of Study   Clinical evaluation of Artava janana property of Jyotishmati,Vacha,Asan,Swarjika kshar (JVAS)compound in Rajonasha 
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 Sarita Saroj 
Designation  Junior Resident 
Affiliation  Institute of Medical Science BHU 
Address  Department of Prasuti Tantra Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  9598881924  
Fax    
Email  saritaghazipur94@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shikha Singh 
Designation  Assistant Professor 
Affiliation  IMS BHU 
Address  Department of Prasuti Tantra Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  9453663997  
Fax    
Email  shikha151984@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shikha Singh 
Designation  Assistant Professor 
Affiliation  IMS BHU 
Address  Department of Prasuti Tantra Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  9453663997  
Fax    
Email  shikha151984@gmail.com  
 
Source of Monetary or Material Support  
Sir Sundarlal Hospital Faculty of Ayurveda IMS, BHU Varanasi, UP, India Picode-221005 
 
Primary Sponsor  
Name  Institute of Medical Science Department of Prasuti Tantra 
Address  Faculty of Ayurveda IMS, BHU Varansai, UP, India Pin code -221005 
Type of Sponsor  Research institution 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 
Dr Sarita Saroj  Sir Sundarlal Hospital  Faculty of Ayurveda Department of Prasuti Tantra IMS BHU
Varanasi
UTTAR PRADESH 
9598881924

saritaghazipur94@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Banaras Hindu University, Institute of Medical Sciences, Varanasi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N911||Secondary amenorrhea. Ayurveda Condition: RAJONASAH (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Wheat powder (placebo)Refereance not available Route oral Dosage form powder Dose 2gm Frequency Qid Duration 3 days Taken with milk
2Intervention ArmDrugClassical(1) Medicine Name: Jyotishmati, vacha, Asan, Swarjika Kshar, Reference: Bhav Prakash, Chikitsa Sthan 70/22-24, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: qid, Bhaishajya Kal: Adhobhakta, Duration: 3 Days, anupAna/sahapAna: Yes(details: -milk), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Amenorrhoea of at least 60 days 
 
ExclusionCriteria 
Details  Patients below the age of 18 years and above the age of 40 years.

Pregnant women, lactating mothers, menopause.

Congenital anomalies (mullerian agenesis, cryptomenorrhea)

Surgical Menopause and Oophorectomy.

Patient having organic pathology of uterus & adnexa like cervical carcinoma or any

malignant growth.

Patients having neoplasia and on radiotherapy.

Patients taking any hormone except Thyroxin.

Patients using hormonal contraception (oral/ injectable/transdermal /Intra-uterine)

Patients on Anti-psychotic drugs.

Patients who cannot attend follow-up regularly. Who is participating in another study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Restoration of Menses  Three follow ups in 5th day 15th day and 30th day 
 
Secondary Outcome  
Outcome  TimePoints 
Restoration menstruation & regulation of amount of menstrual flow & pain during menses  Three follow ups in 5th day 15th day & 1 month 
 
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 3 
Date of First Enrollment (India)   15/09/2024 
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="0"
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  
In the present scenario, menstrual disorder is the commonest gynecological problem in females of the reproductive age group. On account of the disturbance in proper diet, rest, stress, and strain with the change of lifestyle, menstrual disorders have become a very challenging problem for working women or housewife. These may involve structural or functional disturbances and are mostly associated with the complaint of infertility, psychological problems, obesity etc.

Prevalence of secondary amenorrhea has been reported to be 3-4%. Regardless of diagnosis, oligomenorrhoea and amenorrhea are changes in regular menstrual cycles which include long menstrual cycles and absence of menstruation respectively.

The hormonal therapy based on estrogen and progesterone compound is the mainstay of the treatment for these conditions and long-term use of these drugs may produce many side effects. That’s why nowadays there has been an increasing trend in the use of complementary and alternative medicine.

Rajonasha can be correlated with amenorrhea, for which various Shaman and Shodhan drugs are described in the Ayurvedic classics. These all drugs are mainly Agneya. Agneya dravya will increase pitta and Artava due to same properties, with concept of samanya vriddhi karanam.Ayurvedic medicines cure rajonasha by improving Agni and remove of shroto- avarodha. By using these potent Ayurvedic medicines, side effects of the hormonal treatment can be avoided.

Therefore, the present study is undertaken to evaluate the artavajana property of JVAS (Jyotishmati, Vacha, Asan, Swarjikakshar) compound and in the management of Rajonasha.

 
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