| 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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N911||Secondary amenorrhea. Ayurveda Condition: ARTAVAVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Tab Norethisterone 5 mg | 1 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. |