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CTRI Number  CTRI/2025/04/085134 [Registered on: 21/04/2025] Trial Registered Prospectively
Last Modified On: 20/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   The effect of An Ayurvedic Indigenous Drug Compound and Norethisterone tablet in induction of menstruation 
Scientific Title of Study   An open label randomised controlled clinical study to evaluate the effect of An Ayurvedic Indigenous Drug Compound and Norethisterone tablet in induction of menstruation. 
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 Laxmi Iranna Benur 
Designation  PG Scholar 
Affiliation  JSS Ayurveda Medical College And Hospital, Mysuru. 
Address  Department Of Prasuti Tantra And Stree Roga 41/E, Lalithadripura Road, Alanahalli, Mysuru, Karnataka-570028, India.

Mysore
KARNATAKA
570028
India 
Phone  9148873719  
Fax    
Email  benurlaxmi059@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Usha D T 
Designation  Professor 
Affiliation  JSS Ayurveda Medical College And Hospital, Mysuru. 
Address  Department Of Prasuti Tantra And Stree Roga 41/E, Lalithadripura Road, Alanahalli, Mysuru, Karnataka-570028, India.

Mysore
KARNATAKA
570028
India 
Phone  9164455019  
Fax    
Email  usha.ayurveda@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Usha D T 
Designation  Professor 
Affiliation  JSS Ayurveda Medical College And Hospital, Mysuru. 
Address  Department Of Prasuti Tantra And Stree Roga 41/E, Lalithadripura Road, Alanahalli, Mysuru, Karnataka-570028, India.

Mysore
KARNATAKA
570028
India 
Phone  9164455019  
Fax    
Email  usha.ayurveda@gmail.com  
 
Source of Monetary or Material Support  
JSS Ayurveda Medical College And Hospital, OPD 9, Department Of Prasuti Tantra And Stree Roga 41/E, Lalithadripura Road, Alanahalli, Mysuru, Karnataka-570028, India.  
 
Primary Sponsor  
Name  Dr Laxmi Iranna Benur 
Address  JSS Ayurveda Medical College And Hospital 41/E, Lalitharipura Road, Alanahalli, Mysuru-570028  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
JSS AYURVEDA MEDICAL COLLEGE AND HOSPITAL  41/E, LALITHARIPURA ROAD, ALANAHALLI, MYSURU-570028 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Laxmi Iranna Benur  JSS Ayurveda Medical College And Hospital   OPD No.9, Department Of Prasuti Tantra And Stree Roga 41/E, Lalithadripura Road, Alanahalli, Mysuru, Karnataka-570028, India.
Mysore
KARNATAKA 
9148873719

benurlaxmi059@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL HUMAN ETHICS COMMITTEE  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: ARTAVAVAHASROTOVIKARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: An Ayurvedic Indigenous Drug Compound, Reference: Anubhoota Yoga( A Combination of four Artavajanana Drugs), Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 10 Days, anupAna/sahapAna: Yes(details: Honey), Additional Information: -
2Comparator Arm (Non Ayurveda)-Tab Norethisterone 5 mg1 tablet, thrice a day, after food for 7 days
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. Both married and unmarried female with age group of 16-40 yrs.

2. subjects with more than 40 days of amenorrhea.  
 
ExclusionCriteria 
Details  Amenorrhea due to pregnancy and lactation.

Patient with malnutrition (BMI less than 18.00), anemia (less than 9gm),

Subjects with Primary amenorrhea .

Subjects taking steroid medications or under long term medication for chronic illness.

Subjects with known case of GERD.

Subjects with known case of premature ovarian failure.

Diagnosed case of reproductive tract Diseases such as Pelvic Inflammatory Diseases, Genital Tuberculosis, Benign and Malignant lesions of Reproductive organs and other Congenital deformities.

Known case of other Chronic illness Like Cardiac diseases, Thyroid Disorders and Diabetes mellitus. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The effect of An Ayurvedic Indigenous drug compound in induction of menstruation.
The effect of Norethisterone in induction of menstruation.
The Efficacy Of Oral Administration Of An Ayurvedic Indigeneous drug compound Versus Norethisterone Tablet in induction of menstruation.
 
0th day, 11th day
0th day, 8th day to 17th day 
 
Secondary Outcome  
Outcome  TimePoints 
The Timing Of Withdrawal Bleeding During And After The Medication And Their Compliance With Treatment Will be Considered   0th day, 11th day,15 TH DAY
0th day, 8th day to 17th day 
 
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)   01/05/2025 
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  

The absence of  menstruation is called amenorrhea, it can classified as physiological and pathological amenorrhea. Physiological amenorrhea like wise in pregnancy, lactation and menopause . Pathological amenorrhea is  due to pathology in endocrine or the uterine-ovarian axis. Pathological amenorrhea  is  commonly seen in day to day OPD’s with prevalence rate of 3 to 4% world wide and 21.3% in India. Ayurveda is a science that focuses on the quality of living, aims not only in curing the disease rehabilitating but also in preventing it. In the present scenario, the pathological amenorrhea is one of the gynecological issues which affects the quality of life of a woman and has a wider impact on her physical, psychological and social well-being. In Ayurveda classics the word ’Artava denotes two meanings one of them is Antah Pushpa and another one is Bahir Pushpa. Both are interrelated. Bahir Pushpa is outward manifestation of appropriate work of Antah Pushpa which is neccesory for conception. Here, the present study deals with Bahir Pushpa that is Menstrual blood. The word Artava is also used in our Sastras in various contexts to refer (Dhatu upadhatu roopa artava) hormones, (Beejaroopa artava) ovum and (rajas) menstrual blood.  Acharyas have mentioned various terms for absence of Artava i.e Nashtartava by Sushruta, Anartava by Vagbhata, absence of Raja by Bhela & Rajonasha by Bhavaprakasha. 

In Ayurveda, Anarthava as a symptom is taken up as temporary imbalance of the presiding factors like Doshadushtilakshana, or as a symptom of a disease Vyadhilakshana. The pathophysiology of Anartava can be understood as there is no proper formation of artava or their will be kapha and vata obstructs the passage or orifices of channels carrying artava (artava vaha srotas), thus there will be no menstrual discharge. Since the Sushruta told, the treatment of anartava is directly mentioned as kaphavatahara and pittavardaka dravyas as like "Artava shonitam tu agneyam“. Vagbhata says "pittalai upacharet pravartamanam“  

So as per references we have planned to  administer pittavardaka(agneya) dravyas for induction of             menstruation i.e artavajanana or artava pravatana or rajapravrutti 

Now a days the prevalence rate of amenorrhea is increasing day by day may due to unhealthy foods and lifestyle or some other causes. And women seeking treatment like hormone replacement therapy. In contemporary science progestins are widely used to alter (to induce/to stop) menstruation which are having its own adverce drug  reaction like breast discomfort, muscle ache, abnormal vaginal discharge and so on. As of now there is no ayurvedic formulation practiced for symptomatic treatment in amenorrhea. Hence there is need for the safe, potent and effective drug for induction of menstruation. So it will be a great boon to the women if it can be replaced by natural remedies with no side effects. 

A pilot study was conducted on 8 subjects with history amenorrhea. Out of 8 subjects 4 attained menstruation with in 15 days and 2 subjects reported  as feeling of menstrual symptoms like heaviness of abdomen,whitedischarge per vagina  but bleeding not appreciated.2 subjects remained unchanged. About 40% of the patients required only less than 10 days for induction of menstruation with the medicine, 10% required upto 15  days and 50% no induction of menstruation seen. 

So need to conduct the study in increased sample size and to know the effectiveness of an Ayurveda indigenous drug compound in induction of menstruation.  

 
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