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CTRI Number  CTRI/2020/10/028229 [Registered on: 05/10/2020] Trial Registered Prospectively
Last Modified On: 21/09/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   To Study the effect of Udumber Twak Ghanvati in Asrugdara. 
Scientific Title of Study   Single arm clinical study to evaluate efficacy of Udumbar Twak Ghanvati in Asrugdara. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sayali Gourishankar Belage 
Designation  MS Scholar streerog prasutitantra 
Affiliation  Dr D Y Patil ayurvedic college pimpri pune 
Address  Opd no 2 Dr D Y Patil college of ayurved and research center pimpri pune Sant tukaram nagar,pimpri colony,pimpri chinchwad 411018 pune MAHARASHTRA 411018 India

Pune
MAHARASHTRA
411018
India 
Phone  9049815314  
Fax    
Email  sayalibelage261993@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Hridaynath Lad 
Designation  MD streerog & prasutitantra 
Affiliation  Dr D Y Patil ayurvedic college pimpri pune 
Address  Opd no 2 Dr D Y Patil college of ayurved and research center pimpri pune Sant tukaram nagar,pimpri colony,pimpri chinchwad 411018 pune MAHARASHTRA 411018 India

Pune
MAHARASHTRA
411018
India 
Phone  9822964454  
Fax    
Email  hridaynath.lad@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sayali Gourishankar Belage 
Designation  MS Scholar streerog prasutitantra 
Affiliation  Dr D Y Patil ayurvedic college pimpri pune 
Address  Opd no 2 Dr D Y Patil college of ayurved and research center pimpri pune Sant tukaram nagar,pimpri colony,pimpri chinchwad 411018 pune MAHARASHTRA 411018 India

Pune
MAHARASHTRA
411018
India 
Phone  9049815314  
Fax    
Email  sayalibelage261993@gmail.com  
 
Source of Monetary or Material Support  
Dr D Y Patil ayuveda and research centre pimpri pune 411018 
 
Primary Sponsor  
Name  Dr Sayali Gourishankar Belage 
Address  Dr D Y Patil ayuveda and research centre pimpri pune 411018 
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 Sayali Gourishankar Belage  Dr D Y Patil college of ayurved and research center pimpri pune   Streerog and prasutitantra Opd no 2 Dr D Y Patil college of ayurved and research center pimpri pune Sant tukaram nagar,pimpri colony,pimpri chinchwad 411018 pune MAHARASHTRA 411018 India
Pune
MAHARASHTRA 		 9049815314

sayalibelage261993@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research and Recognition committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  60 patients will be selected for trial,They should not have any chronic systemic disorder 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  Udumbar Twak Ghanvati  60 patients will be selected and treated with Udumbar twak Ghanvati and dose will be 500mg once in a day with dugdhasharkara yukta annapan.Duration of study will be 3 months ( 3 Consecutive cycles) for 1st 5 days of menstrual flow. 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1) Written informed consent & voluntarily willing patients will be taken for this study.
2)Patients complaining of excessive or prolonged menstrual bleeding or inter menstrual bleeding for 2 consecutive cycles.
3)Hb % - Above 8 gm%.

 
 
ExclusionCriteria 
Details  1)Patients with IUCD and on OC pills or on hormonal treatment.
2)PCOD,STD,Blood coagulopathy.
3) Immuno– compromised patients.
4)Associated with other systemic diseases like HTN, TB, DM.
5)Bleeding from polyps,fibroid, Ca, erosions, trauma etc.
6)On medication like Aspirin, clopitab.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1)Asrugdara is the common problem noticed in majority of patients in our clinical practice.
2) To evatuate and establish safer,cost-effective Ayurvedic remedy for Asrugdara.

 		 Patient should be assessed for 3 consecutive cycles for 1st 5 days of menstrual flow

 
 
Secondary Outcome  
Outcome  TimePoints 
1)To improve physiological condition
2)To give her a safe cheap side effect free ayurvedic management 		 90 days 
 
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 
Date of First Enrollment (India)   21/10/2020 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Aim of the study will be to give ayurvedic treatment to diseased patient to improve her condition and we can give her cheap, safe side effect free management .
The trial will be conducted on 60 patients for 3 consecutive cycle of 1st 5 days of menstrual flow and dose will be 500mg once in a day and conclusion will be drawn from the collected data.
 
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