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CTRI Number  CTRI/2024/08/073099 [Registered on: 29/08/2024] Trial Registered Prospectively
Last Modified On: 27/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Ayurvedic Management on effect of Vamana and Palasha Niruha Basti in Polycystic Ovarian Syndrome 
Scientific Title of Study   Clinical Study To Evaluate The Effect Of Vamana and Palasha Niruha Basti in Artava Kshaya WSR to PCOS 
Trial Acronym  NL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr.Sandeep Kumar 
Designation  MD Scholar 
Affiliation  DR BRKR GOVT AYURVEDIC COLLEGE ,ERRAGADA HYDERABAD 
Address  Room No 5 Department of Panchakarma DR.Brkr Govt Ayurvedic Medical college and Hospital Erragadda Hyderabad

Hyderabad
TELANGANA
500038
India 
Phone  9149463402  
Fax    
Email  sandeepangural7298@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Praveen kumar Madikonda 
Designation  Professor 
Affiliation  DR BRKR GOVERMENT AYURVEDIC COLLEGE AND HOSPITAL 
Address  ROOM NO 5 Department of Panchakarma Dr BRKR Govt Medical College and Hospital erragadda Hyderabad 500038

Hyderabad
TELANGANA
500038
India 
Phone  9849271601  
Fax    
Email  pkmadikonda@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sandeep Kumar 
Designation  MD Scholar 
Affiliation  Dr. BRKR Government Ayurvedic college 
Address  ROOM NO 5 DEPARTMENT OF PANCHAKARMA DR BRKR GOVERMENT AYURVEDIC COLLEGE AND HOSPITAL,ERRAGADA HYDERABAD

Hyderabad
TELANGANA
500038
India 
Phone  9849271601  
Fax    
Email  sandeepangural7298@gamil.com  
 
Source of Monetary or Material Support  
Dr.brkr Govt Ayurvedic Hospital Errgadda Hyderabad 500038 
 
Primary Sponsor  
Name  Dr Brkr government Ayurvedic medical College 
Address  Dr Brkr Ayurvedic Medical College And Hospital Erragadda Hyderabad 500038 
Type of Sponsor  Government 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 Sandeep kumar  DR.BRKR GOVT AYURVEDIC COLLEGE AND HOSPITAL  ROOM NO 5 DEPARTMENT OF PANCHAKARMA OPD ERRAGADDA SR NAGAR
Hyderabad
TELANGANA 		 9149463402

sandeepangural7298@gamil.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE of DR BRKR GOVT AYURVEDA COLLEGE HYDERABAD  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E282||Polycystic ovarian syndrome. Ayurveda Condition: ARTAVAKSHAYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-vamana-karma/ pracCardanam, वमन-कर्म/ प्रच्छर्दनम् Pradhan Karma(Procedure Reference: charak siddhi , Procedure details: snehapana with sukumara Ghrita vamana with Madanaphaladi Yoga followed by Samsarjana Krama.)
2Intervention ArmProcedure-yoga-bastiH, योग-बस्तिः (Procedure Reference: charak siddhi, Procedure details: Palashadi Niruha basti in 2 cycle with gap of 7 to 10 days)
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  A) Atleast one ovary showing PCO (diagnosed by USG)

B) PCOS patients with Age between 18 to 35 years suffering from any of the two following features :-

1. Duration of menstrual flow less than 2 days.
2. Interval between 2 cycles exceeding more than 35 days.
3. Patients suffering withoilgomenorrhoea and or anovulation.
4. Patients having hirsutism /acne/Acanthosis nigricans/alopecia
5. Patients having mid body obesity.(BMI more than 25 )
6. Patient with HbA1C - less than 9.
7. Patient who are willing to sign consent form .
8.Patient who is eligible for Vamana & Palasha niruha Basti 
 
ExclusionCriteria 
Details  1. Patient below age of 18yr and above age of 36 years.
2. Pregnant women ,Lactating mother.
3. Patients suffering from any systemic diseases.
4. Patient having congenital and structural abnormalities of uterus and adnexae.
5. Patient with HbA1C – more than 9.
6. Drug induced amenorrhoea / oligomenorrhoea,menorrhagia .
7. HIV ,VDRL, HCV,HBsAgpositive,TB ,Genetic disorders.
8. Patients suffering from pelvic pathology including fibroid uterus , cervical polyp etc..
9. HB level less than 8 gm%.
10. Patient who is not eligible for Vamana & Palasha Niruha Basti 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Hairfall is reduced,
Regular menstrual cycle.
Reduction of weight
 		 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Reduce the size of cyst
Reduction of BMI 		 18 months 
 
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   N/A 
Date of First Enrollment (India)   14/09/2024 
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 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   This is randomised clinical trail, to evaluate the effect of vamana and palasha niruha basti in artava kshaya w.s.r to pcos In patient  who will be clinically diagnosed and confirmed the case of pcos enlisted in inclusion criteria od single group of total 30 patient .They will be given vamana and palasha niruha basti .Follow upto 53 days.in interval 15 days.  
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