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CTRI Number  CTRI/2024/02/062628 [Registered on: 14/02/2024] Trial Registered Prospectively
Last Modified On: 08/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   ARTAVA KSHAYA W.S.R TO OLIGOMENORRHEA AND HYPOMENORRHEA 
Scientific Title of Study   A COMPARATIVE CLINICAL STUDY OF KRISHNA TILA KWATHA AND VENUPARVADI KWATHA ON ARTAVA KSHAYA W.S.R TO OLIGOMENORRHEA AND HYPOMENORRHEA 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bhavna Khandagre 
Designation  P.G. Scholar 
Affiliation  Mansarovar Ayurvedic Medical College  
Address  PG Department of Prasuti Tantra Evum Stri Roga Mansarover Ayuevedic Medical College Hospital and Research Center Ward No 84 Rani Avanti Bai Kolar Road Bhopal Pin Code - 462042 Madhya Pradesh India

Bhopal
MADHYA PRADESH
462042
India 
Phone  9617130470  
Fax    
Email  bhavanakhandagre@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sucheta Ray 
Designation  Professor & HOD 
Affiliation  Mansarovar Ayurvedic Medical College  
Address  PG Department of Prasuti Tantra Evum Stri Roga Mansarover Ayuevedic Medical College Hospital and Research Center Ward No 84 Rani Avanti Bai Kolar Road Bhopal Pin Code - 462042 Madhya Pradesh India

Bhopal
MADHYA PRADESH
462042
India 
Phone  7415288345  
Fax    
Email  sucheta.ray1@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ekta Singh Parihar 
Designation  Assistant Professor 
Affiliation  Mansarovar Ayurvedic Medical College  
Address  PG Department of Prasuti Tantra Evum Stri Roga Mansarover Ayuevedic Medical College Hospital and Research Center Ward No 84 Rani Avanti Bai Kolar Road Bhopal Pin Code - 462042 Madhya Pradesh India

Bhopal
MADHYA PRADESH
462042
India 
Phone  9753615061  
Fax    
Email  ektaparihar47@gmail.com  
 
Source of Monetary or Material Support  
Mansarovar Ayurvedic Medical college Kolar Road Bhopal 
 
Primary Sponsor  
Name  Mansarovar Ayurvedic Medical college Bhopal 
Address  Mansarovar Ayurvedic Medical college Kolar Road Bhopal Pin Code-462042 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Dr Bhavna Khandagre  PG Department of Prasuti tantra And Stri Roga Mansarovar Ayurvedic Medical college Kolar Road Bhopal 462042 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bhavna Khandagre  Mansarovar Ayurvedic Medical college Bhopal  OPD No.2 Prasuti Tantra and Stri Roga IPD Ward Room No. 101 and 102 Mansarovar Ayurvedic Medical college Kolar Road Bhopal Pin 462042
Bhopal
MADHYA PRADESH 		 9617130470

bhavanakhandagre@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutinal ethics committe Mansarovar Ayurvedic Medical college Hospital And Research Center Approved by CCIM New Delhi and Affiliated to M P Medical Science University Jabalpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Good And Health Condition 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Krishna Tila Kwatha, Reference: Yog ratnakar yonivyapad chikitsa 3, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Venuparvadi Kwatha, Reference: Siddha bheshaja manimala stri roga chikitsa 5, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: praksepa guda 10gm), Additional Information: Both the Groups will be Given Medication for 90 days. 1 st Assessment will be done on -30th day. 2 nd Assessment will be done on -60th day. 3 rd Assessment after treatment will be done -90 days.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1.The patients having classical symptoms of Artava Kshaya as per the classical references will be selected.
2.The patient above 18 years of age and below under 45 years.
3.Duration of flow less than 3 days with reduced
quantity of flow (using less than 2 pads day)
4.Patients suffering from 2 minimum consecutive cycle with Oligomenorrhea.
5.Patients suffering from 2 minimum consecutive cycle with Hypomenorrhea.
 
 
ExclusionCriteria 
Details  1.Patients having severe systemic disorders like Diabetes, Thyroid, Hormonal imbalance and Uterine TB from the study.
2.Patients taking for oral contraceptive pills.
3.Lactating mother.
4.Pregnant women.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1 Duration of menstrual bleeding is normal.
2 interval between to menstrual bleeding. 20-30 day
3 No pain During Menstruation. 		 1 Duration of menstrual bleeding 4-7 day.
2 interval between to menstrual bleeding 20-30 day
3 zero pain During menses.
 
 
Secondary Outcome  
Outcome  TimePoints 
1 After intervention Duration of menstrual bleeding is normal in 90 days.
2 Menstrual bleeding. 20-30 day.
3 No pain During Menstruation.
 		 1 Duration of menstrual bleeding 4-7 day.
2 interval between to menstrual bleeding 20-30 day
3 zero pain During menses. 
 
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 2/ Phase 3 
Date of First Enrollment (India)   28/02/2024 
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="3"
Days="15" 
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  

In Artava kshaya- Menstruation is delayed, Menstrual blood is scanty and associated with pain in Vagina. The symptoms of Artava Kshaya according to Acharya Sushruta are Yathochitakala Adarshanam (amenorrhea), Alpata (oligomenorrhea), Yonivedana (pain in vaginal region). In Modern Menstrual disorders, Artava kshaya can be correlated with Hypomenorrhea and Oligomenorrhea. By Acharya Vagabhata the word ‘Artava kshaya’ is not clealy used but the word ‘Kshinartava’ has been used which is actually a synonym of ‘Artava Kshaya.’ Acharya Bhel has described ‘Alpartava’ and ‘Vikritaartava’ they are also synonymous of ‘Artava Kshaya’. Sharangdhara has mentioned ‘Kshinartava’ as synonymous of ‘Artava kshaya’. It may be due to nutritional deficiency & decrease in Rasa and Rakta Dhatu and Upadhatu (Raja/Artava) it can be compared with Oligomenorrhea or Hypomenorrhea described in modern medical science, in which hormonal disorders occurs due to disturbance in co-ordination of hypothalamus-pituitary ovarian axis. The over all effects of the krishna tila kwatha (orally) And venuparvadi kwatha is more effective to increase the duration of menstrual period interval decrease between to menstrual cycles and increase in amount of menstrual bood.

 
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