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CTRI Number  CTRI/2024/07/070060 [Registered on: 05/07/2024] Trial Registered Prospectively
Last Modified On: 04/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to evaluate the effect of Jeevantyadi Yamaka enema therapy in irregular and scanty menstrual cycle/ Oligomenorrhea  
Scientific Title of Study   A Randomized open- labelled controlled clinical study to evaluate the efficacy of Jeevantyadi Yamaka Matra Basti in the management of Artava Kshaya with special reference to Oligomenorrhea  
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 Aishwarya B 
Designation  PG Scholar 
Affiliation  Sri Sri College of Ayurvedic Science and Research 
Address  Department of Prasuti Tantra And Stree Roga, Room No. 10, Sri Sri College of Ayurvedic Science and Research Hospital, Kanakapura Road, Udayapura P.O, Bangalore- 560082

Bangalore
KARNATAKA
560082
India 
Phone  7022218814  
Fax    
Email  aishwaryabmoolya@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rachana H V 
Designation  Professor 
Affiliation  Sri Sri College of Ayurvedic Science and Research 
Address  Department of Prasuti Tantra And Stree Roga, Room No. 10, Sri Sri College of Ayurvedic Science and Research Hospital, Kanakapura Road, Udayapura P.O, Bangalore- 560082

Bangalore
KARNATAKA
560082
India 
Phone  9535744077  
Fax    
Email  dr.rachanabhat@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Aishwarya B 
Designation  PG Scholar 
Affiliation  Sri Sri College of Ayurvedic Science and Research 
Address  Department of Prasuti Tantra And Stree Roga, Room No. 10, Sri Sri College of Ayurvedic Science and Research Hospital, Kanakapura Road, Udayapura P.O, Bangalore- 560082

Bangalore
KARNATAKA
560082
India 
Phone  7022218814  
Fax    
Email  aishwaryabmoolya@gmail.com  
 
Source of Monetary or Material Support  
Sri Sri College of Ayurvedic Science and Research Hospital 21st KM OB chudahalli , Kanankpura road , Bengaluru 560082 
 
Primary Sponsor  
Name  Dr Aishwarya B 
Address  Sri Sri College of Ayurvedic Science and Research, Kanakpura Road, Udayapura P.O, 560082 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Sri Sri College of Ayurvedic Science and Research   Kanakpura Road Udayapura P.O, 560082 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aishwarya B  Sri Sri College of Ayurvedic Science and Research  Department of Prasuti Tantra And Stree Roga, Room No. 10, Sri Sri College of Ayurvedic Science and Research Hospital, Kanakapura Road, Udayapura P.O, Bangalore- 560082
Bangalore
KARNATAKA 		 7022218814

aishwaryabmoolya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Sri Institutional Ethical Committe   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N915||Oligomenorrhea, unspecified. Ayurveda Condition: ARTAVAKSHAYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: Charaka samhita siddhi sthana 4/52 , Procedure details: Poorva karma- Subjects will be asked to come for the treatment immediately after taking food. Stanika Abhyanga to abdomen, gluteal region & thighs with respective Sneha will be done followed by Ushma Sweda for 20 minutes. Pradhana karma- Subjects will be asked to lie in the left lateral position by keeping left leg straight and right leg flexed at the knee joint. Under aseptic precautions, anal orifice will be anointed by using cotton swab dipped in oil and 72ml of respective Sneha will be administered using rubber catheter attached to syringe. Paschat karma- Gentle tapping over the buttocks will be done. Patient will be advised to pass bowel after getting the urge.)
(1) Medicine Name: Jeevantyadi Yamaka, Reference: Charaka Samhita Siddhi Sthana 4/9, Route: Rectal, Dosage Form: Ghrita, Dose: 72(ml), Frequency: od, Duration: 7 Days
2Comparator ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: Charaka Samhita Siddhi Sthana 4/52, Procedure details: Poorva karma- Subjects will be asked to come for the treatment immediately after taking food. Stanika Abhyanga to abdomen, gluteal region & thighs with respective Sneha will be done followed by Ushma Sweda for 20 minutes. Pradhana karma- Subjects will be asked to lie in the left lateral position by keeping left leg straight and right leg flexed at the knee joint. Under aseptic precautions, anal orifice will be anointed by using cotton swab dipped in oil and 72ml of respective Sneha will be administered using rubber catheter attached to syringe. Paschat karma- Gentle tapping over the buttocks will be done. Patient will be advised to pass bowel after getting the urge.)
(1) Medicine Name: Phalakalyana Ghrita , Reference: Bhaishajyaratnavali 67/78-84, Route: Rectal, Dosage Form: Ghrita, Dose: 72(ml), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1)Subjects between the age group of 20- 40 years.
2)Subjects irrespective of marital status and parity.
3)Subjects presenting the classical symptoms of Artavakshaya.
4)Subjects with symptoms of Oligomenorrhea.
5)Subjects suffering from Artavakshaya for more than 2 cycles.
6)Subjects with spotting/bleeding less than 2 days.
7)Subjects with or without pain during menstruation.
8)Subjects after 3 months of withdrawal of oral contraceptive pills and removal of intra uterine contraceptive device.
9)Subjects willing to sign the consent form.
 
 
ExclusionCriteria 
Details  1)Subjects who are pregnant and lactating mothers.
2)Subjects with hemoglobin less than 10g%.
3)Subjects with congenital malformation of uterus.
4)Subjects with known case of hemorrhoids, fistula, fissures.
5)Subjects with known case of chronic systemic illness and malignancy 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Significant decrease in symptoms of Artavakshaya with special reference to Oligomenorrhea based on assessment criteria.
a.Interval between two cycles
b.Amount of menstrual bleeding loss.
c.Duration of menstrual flow
d.Intensity of pain during menstruation.
e.Assessment of pain- Grading by VMS.

2.The efficacy of Jeevantyadi Yamaka Matra Basti will be established in the treatment of Artavakshaya.
Efficacy shall be assessed based on assessment criteria mentioned above. 		 Pre assessment-0th day
1st assessment-1st cycle after treatment- 1month
Follow up-2nd cycle without treatment- 2 month 
 
Secondary Outcome  
Outcome  TimePoints 
1.Generation of in- depth analysed data on the different aspect of the disease.
2.Generation of data on possible unexpected drug reaction.
 		 1 year 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/08/2024 
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  
In the current era, emphasizing the significance of women’s health is crucial. While maintaining good health should be a priority but women are entangled in demanding routines and may not allocate sufficient time to ensure their health and well-being.
Menstruation is a vital sign of a women’s reproductive and overall health, menstrual irregularities can signal underlying medical conditions.
The word Artava encompasses menstruation, menstrual blood, as well as ovum and ovarian hormones. 
Artava Vyapat has become increasingly prevalent in the modern era due to unhealthy dietary patterns, sedentary lifestyles, heightened stress levels, and other contributing factors.
Oligomenorrhea is the term used to describe Menstrual bleeding occurring more than 35 days apart and which remains constant at that frequency.
Basti Karma is one of the effective treatment that can be employed in the treatment of Artava Kshaya as it helps in Shodhana of Shrotas.
Matra Basti is a type of Anuvasana Basti in which the low dose of Sneha is administered with no major contraindication.
 In order to treat Rajo Dosha ,Jeevantyadi Yamaka  is considered, as the drugs in the formulation  have properties to enhance the Rasa Dhatu which in turn acts on its Upadhathu - Artava..
Hence Matra Basti with Jeevantyadi Yamaka  is opted as the treatment of choice  in Artavakshaya aiming to eradicate the disease at its core.
 
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