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CTRI Number  CTRI/2024/06/068662 [Registered on: 11/06/2024] Trial Registered Prospectively
Last Modified On: 25/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Homoeopathy In Primary Dysmenorrhoea With Jonosia Asoka 
Scientific Title of Study   A prospective experimental study to know the effectiveness of jonosia asoka in the cases of primary dysmenorrhoea with the help of WALIDD score 
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 Megha Maheshkumar Vyas 
Designation  PG Scholar 
Affiliation  Rajkot Homoeopathic Medical College, Parul University 
Address  Department Of Homoeopathic Materia Medica, Rajkot Homoeopathic Medical College, behind jainath complex, makkam chowk, Rajkot

Rajkot
GUJARAT
360002
India 
Phone  09429923463  
Fax    
Email  meghavyas2911@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kamna Umesh Gupta 
Designation  Assistant Professor 
Affiliation  Rajkot Homoeopathi Medical College 
Address  Department Of Homoeopathic Materia Medica, Rajkot Homoeopathic Medical College, behind jainath complex, makkam chowk, Rajkot

Rajkot
GUJARAT
360002
India 
Phone  9029147800  
Fax    
Email  drkamnagupta@yahoo.in  
 
Details of Contact Person
Public Query
 
Name  Dr Kamna Umesh Gupta 
Designation  Assistant Professor 
Affiliation  Rajkot Homoeopathi Medical College 
Address  Department Of Homoeopathic Materia Medica, Rajkot Homoeopathic Medical College, behind jainath complex, makkam chowk, Rajkot

Rajkot
GUJARAT
360002
India 
Phone  9029147800  
Fax    
Email  drkamnagupta@yahoo.in  
 
Source of Monetary or Material Support  
Rajkot Homoeopathic Medical College, Gondal Rd, Near Makkam Chowk, Udhyog Nagar Colony, Bhakti Nagar, Rajkot, Pincode-360002, Gujarat, India 
 
Primary Sponsor  
Name  Rajkot Homoeopathic Medical College 
Address  Rajkot Homoeopathic Medical College, behind jainath complex, makkam chowk, Rajkot 
Type of Sponsor  Private medical college 
 
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 Megha Maheshkumar Vyas  Rajkot Homoeopathic Medical College  Department Of Materia Medica,Rajkot Homoeopathic Medical College, behind jainath complex, makkam chowk, Rajkot
Rajkot
GUJARAT 
09429923463

meghavyas2911@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Comittee For Human Research Rajkot Homoeopathic Medical College (RHMC) Parul University Gujarat  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N944||Primary dysmenorrhea,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Jonosia Asoka  Jonosia Asoka will be prescribed Mode Of Administration : oral (sublingual) selection of potency: 6, 30, 200, 1M potency selection of potency and dosage: potency and repitition will be according to susceptibility of patient and principles of organon of medicine and will be done every month after follow up till 6 months. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  19.00 Year(s)
Gender  Female 
Details  nulliparous females.
females having no pelvic pathology.
age group since menarche to 19 years of age.
females having regular menstrual cycle. 
 
ExclusionCriteria 
Details  females having any pelvic pathology.
case of secondary dysmenorrhoea are to be excluded.
females above age of 19 years are to be excluded.
patients on OC pills or any other mode of treatment. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To understand the effectiveness of jonosia asoka in the cases of primary dysmenorrhoea with the help of WALIDD Score
To improve the quality of life of the women suffering from primary dysmenorrhea.
Clinical verification of symptoms of primary dysmenorrhoea in adolescent age group.
To assess the clinical utility of WALIDD score.
 
There will be some improvement after prescribing homoeopathic medicine which will be assessed after 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Significant outcome: patient with sense of well being with decrease in score between 1-4.
Moderate improvement: patient wity sense of well being & decrease in score between 5-7.
No improvement or status quo: there is no considerable change observed in complaints & no decrease in score even after administration of medicine. 
There will be some improvement after prescribing homoeopathic medicine after 9 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   N/A 
Date of First Enrollment (India)   01/10/2024 
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="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
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  


Normally life stage of typical women is divided into infancy, puberty(adolescence), sexual maturation (reproductive age), climacteric period and post climacteric period(elderly).

 

Puberty being developmental period where hormonal, psychological and physical change occurs simultaneously; menarche being the first menstrual period in females that typically occurs between the age of 10 -16 years with the average age of onset being 12.4 years. (1)

 

The determinants of menarchial age are socioeconomic condition, genetics, general health, nutritional status, exercise and family’s science.

 

Menarche tends to be painless and occurs without warning when the first cycle is usually anovulatory with varied length and flow. Menarche indicates the biggening of reproductive life and closely associated with the ongoing development of secondary sexual characteristics.

 

Menarche occurs in setting of a maturing normal hypothalamic-pituitary-ovarian axis, normal female reproductive anatomy, good nutrition and absence of any other chronic illness.

 

It is a symbol of normal reproductive health and wellness; almost all females accept menarche as their body’s critical communication of fertility. When the females suffer with lot of pain during menstrual cycle, they don’t convey it or ignore it or he consider it as a part of life.

 

Primary dysmenorrhoea is defined as pain during menstrual cycle in the absence of any other recognisable cause and it is the most common cause of pelvic pain.

 

The impact of primary dysmenorrhea ranges from 45% - 95% in females of reproductive age group worldwide where 2%-29% females experience severe pain and a greater prevalence about 70%- 90% is generally reported in younger females. (1)

 

Primary dysmenorrhoea negatively affects females’ quality of life and interferes with daily activities. The pathophysiology of primary dysmenorrhoea is likely a result of the cyclooxygenase pathway that increase prostanoids particularly prostaglandins. The high level of prostaglandins causes uterine contraction that restrict the blood flow and leads to the production of anaerobic metabolites that stimulates pain receptors.

 

Females with the typical history of primary dysmenorrhoea starts with the empirical treatment that includes pain relieving medications, anti-inflammatory medications, rarely oral combined contraceptive pills, heat application (hot water bag), and regular exercise.

 

Primary dysmenorrhoea is not only a physical issue but it’s a psychosocial issue affecting the life of females. Psychosocial issue in the sense of various orthodox thoughts, beliefs that are followed in the society, their impact on an immature teenager girl makes her more non communicable, antisocial, emotionally vulnerable, and also affects her intellectual skills and abilities.

 

The empirical method of taking medications like pain killers, anti-inflammatory or oral combined contraceptive pills have pros and cons, if we focus on the cons they have a bad effect on the individual in the form of constipation, stomach discomfort, bleeding problem, abnormal weight gain, hepatotoxicity, body swelling etc…

 

So, this being a psychosocial issue in females of vulnerable age group, can homoeopathy help them out?

 

According to WHO the definition of health is “a complete state of physical, mental and social well-being and not merely the absence of disease.” (2)

 

Homoeopathy is a scientific and effective system of holistic healing having a concept of like cures like.

Conventional system works only on the particular part of the body and not on whole body but homoeopathy considers the whole person that is mind, body, emotion. Homoeopathy is system of medicine giving importance to diseased individual rather than disease itself.

 

India is one of the developing countries and very rich in forest and mineral resources. Native medicines of this countries are being ignored as they fail to assess their worth of native herbs under the influence of western drugs.

 

Jonosia asoka plant has important place in Indian culture and it is described in charka Samhita that the effect of Jonosia asoka also known as saraca indica, empirically it was used as analgesic. Jonosia asoka plant has alkaloid - tannin and catechin which has its action on uterus, it lowers the prostaglandin levels that are secreted by endometrial lining during menstruation.

 

 As mentioned in HPI volume-1 Jonosia asoka has widespread action on female reproductive system; it is a great uterine tonic with efficacy in uterine and menstrual disorders. (3)(7)(9)(10)

 

As Jonosia asoka is known for its action in primary dysmenorrhoea but its infrequent use makes its efficacy less known so I had made an attempt to understand it in detail by using it as a uterine tonic for females suffering with this condition and help the community for the same.

 

 

 

 

 

 

 

 

 

 

 
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