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CTRI Number  CTRI/2018/05/013951 [Registered on: 17/05/2018] Trial Registered Retrospectively
Last Modified On: 02/05/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   trial to evaluate the efficacy of inducing vomiting ie mridu vamana and internal administration of bark of Butea monosperma in the form of decoction in reduced mebstrual bleeding with or without regular cycles in diagnosed cases of polycystic ovary 
Scientific Title of Study   an open label single arm clinical study to evaluate the combined effect of mrdu vamana and palasa twak kashaya in artavakshaya in diagnosed case of polycystic ovarian disease. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
IEC-AIMS-2017-AYUR-254  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Akhila A K 
Designation  PG Scholar 
Affiliation  AMRITA SCHOOL OF AYURVEDA 
Address  Dept of Prasuti Tantra and Stri Roga, Amrita School of Ayurveda,Vallikkavu,Kollam Dist.Kerala
TC 27/1109/3 AKHILA ATHYARMADOM TEMPLE LANE, VANCHIYOOR, tvm
Kollam
KERALA
690525
India 
Phone  9495627215  
Fax    
Email  akhila.27.1991@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pradeep Kumar 
Designation  professor 
Affiliation  AMRITA SCHOOL OF AYURVEDA 
Address  Dept of Prasuti Tantra and Stri Roga, Amrita School of Ayurveda,Vallikkavu,Kollam Dist.Kerala
TC 27/1109/3 ATHYARMADOM TEMPLE LANE, VANCHIYOOR, tvm
Kollam
KERALA
690525
India 
Phone  9495627215  
Fax    
Email  drhemavathi.sk@gmail.com  
 
Details of Contact Person
Public Query  
Name  Akhila A K 
Designation  PG Scholar 
Affiliation  AMRITA SCHOOL OF AYURVEDA 
Address  Dept of Prasuti Tantra and Stri Roga, Amrita School of Ayurveda,Vallikkavu,Kollam Dist.Kerala
TC 27/1109/3 AKHILA ATHYARMADOM TEMPLE LANE, VANCHIYOOR, tvm
Kollam
KERALA
690525
India 
Phone  9495627215  
Fax    
Email  akhila.27.1991@gmail.com  
 
Source of Monetary or Material Support  
Akhila A K TC 27/1109/3 Vanchiyoor Tvm Kerala 
 
Primary Sponsor  
Name  AKHILA AK 
Address  PG SCHOLAR DEPT OF PRASUTI TANTRA AND STRI ROGA AMRITA SCHOOL OF AYURVEDA 
Type of Sponsor  Other [self] 
 
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 Akhila A K  amrita school of ayurveda  Opd and Ipd,Dept of Prasuti tantra and Stri roga Amrita school of ayurveda vallikkavu kollam kerala
Kollam
KERALA 		 9495627215

akhila.27.1991@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC,AIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  diagnosed case of polycystic ovary with artavakshaya, (1) ICD-10 Condition: N915||Oligomenorrhea, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Internal medication mrdu vamama and palasa twak kashaya internally  DRUG SCHEDULE: Ashta chÅ«rnam (12gms) for 2 days before food, then Sukumāra ghritam 25 gm bd morning and night with rice gruel prepared with milk and salt for 3 days. Sarvānga Abhyanga Bāshpa Sweda for 1 day with Dhānwantara Tailam and Kaphavridhikara diet, Followed by mridu Vamana with Yashtimadhu phānta, Ksheera (ākanda pāna), and Samsarjana Krama based on Å›uddhi . There after Palāśa twak kashaya (1 pala i.e. 48 gm kashāya chÅ«rnam in 16 pala i.e. 768ml water reduced to 1/8 i.e. 2 pala i.e. 96ml daily) is given till the onset of 2nd menstrual cycle. The mridu Vamana karma will be done for the first cycle only. Duration of study The study will be done for 2 consecutive cycles and assessed for the parameters of menstrual bleeding and interval before treatment and after the treatment ie 7th day of the second cycle 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Age group 18 to 35
Both married and unmarried
Patients with polycystic ovary in USG.
Either flow duration ≤ 2 days or PBAC score ≤ 15
 
 
ExclusionCriteria 
Details  Menstrual cycle < 21 days or > 64 days
Known case of TFT disturbance
Lactating mother
Patient taking OCP/IUCD
Under anti-psychotic, anti-epileptic drugs
Known case of tumors of adrenal or pituitary gland
Patient having systemic pathology like TB, DM, HTN etc.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in
1)Duration of menstrual phase
2)Interval between 2 cycles
3)Amount of bleeding
 		 7th day of 2nd menstrual cycle
 
 
Secondary Outcome  
Outcome  TimePoints 
Understanding of artavakshaya in modern terms  18 months 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   07/12/2017 
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)  Open to Recruitment 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
This study is to assess the combined effect of mrdu vamana  and palasa twak kashaya  in artavakshaya in diagnosed case of polycystic ovarian disease.  
Ashta Choornam 12 gm for 2 days before food, then sukumara ghrtam 25 gm bd with rice gruel prepared with milk and salt for 3 days. SABS for 1 day with
dhanwantara thailam and kapha vridhikara diet followed by mrdu vamana with yastimadhu phanta, ksheera and samsarjana krama based on suddhi.  Thereafter
palasa twak kashaya (1 pala i.e. 48 grm kashaya choornam in 16 pala i.e. 768 ml water reduced to 1/8 i.e. 2 pala i.e. 96 ml daily) is given till the onset of second menstrual cycle.
The mrdu vamana karma will be done for the 1st cycle only.  The study will be done  for two consecutive cycle and assessed for the parameters of mentrual bleeding and 
interval before treatment and after treatment using menstrual chart and PBAC chart The data collected will be formulated and analysed according to appropriate statistical method
 
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