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CTRI Number  CTRI/2020/05/025435 [Registered on: 29/05/2020] Trial Registered Prospectively
Last Modified On: 17/02/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   To find the EFFECT of FEMIGARD GOLD in Menstrual Irregularities 
Scientific Title of Study   A RANDOMIZED, OPEN LABEL, PARALLEL GROUP CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FEMIGARD GOLD IN UTERINE DISEASE CONDITIONS AND MENSTRUAL IRREGULARITIES  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ramesh Kannan 
Designation  Assistant Professor 
Affiliation  KI3, CRO (PM Medical centre) 
Address  Room no:5, Department of Pharmacology,Madras medical college, Near Park Town Station, Park Town, Chennai, Tamil Nadu 600003
Consultant, Room no:10, Medicine OPD, PM Medical Centre, Tamil Nadu.
Chennai
TAMIL NADU
Dr Ramesh Kannan
India 
Phone  7708925866  
Fax    
Email  srkguruvarshan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ramesh Kannan 
Designation  Assistant Professor 
Affiliation  KI3, CRO (PM Medical centre) 
Address  Room no:5, Department of Pharmacology,Madras medical college, Near Park Town Station, Park Town, Chennai, Tamil Nadu 600003
Consultant, Room no:10, Medicine OPD, PM Medical Centre, Tamil Nadu.
Chennai
TAMIL NADU
Dr Ramesh Kannan
India 
Phone  7708925866  
Fax    
Email  srkguruvarshan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ramesh Kannan 
Designation  Assistant Professor 
Affiliation  KI3, CRO (PM Medical centre) 
Address  Room no:5, Department of Pharmacology,Madras medical college, Near Park Town Station, Park Town, Chennai, Tamil Nadu 600003
Consultant, Room no:10, Medicine OPD, PM Medical Centre, Tamil Nadu.
Chennai
TAMIL NADU
Dr Ramesh Kannan
India 
Phone  7708925866  
Fax    
Email  srkguruvarshan@gmail.com  
 
Source of Monetary or Material Support  
Apex Laboratories Private limited 
 
Primary Sponsor  
Name  Apex Laboratories Pvt Ltd 
Address  SIDCO Complex, Guindy, Chennai 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ramesh Kannan  PM Medical Centre  Room no:10, Medicine OPD, PM Medical Centre, Wallajapet, Ranipet, Tamil Nadu.
Vellore
TAMIL NADU 		 7708925866

srkguruvarshan@gmail.com 
Dr Sunita Samal  SRM Medical college Hospital  Kattankulathur, Chennai- 603203
Chennai
TAMIL NADU 		 9944540096

melvingeorge2003@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional ethics committee SRM medical college hospital  Approved 
ki3  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N948||Other specified conditions associated with female genital organs and menstrual cycle,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable  Not applicable 
Intervention  Syrup Femigard gold.   Composition:Each 15 ml has- Asoka (saraca indica)500 mg, Lodhra (symplocos racemosa)300 mg, Ashwagandha (Withania somnifera)200 mg, Shunthi (Zingiber officinale)200 mg. Given orally 15 ml twice daily for 12 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1.Female participants with;
i.Excessive menstrual bleeding
ii. Prolonged menstrual bleeding
iii. Presence of Blood clots in menstrual bleeding
iv. Recurrent Lower abdominal pain
v. Irregular menstrual cycle
vi. USG report suggestive of PCOS (Polycystic ovarian syndrome) and Uterine fibroid for group 1 & 2 respectively.
2. Subjects with stable vitals like pulse and blood pressure
3. Patient should have not participated in any other clinical trial during the past 3 months.
4. Proper written informed consent obtained from the participants before any procedure is performed.  
 
ExclusionCriteria 
Details  1. Presence of any other Pelvic pathology
2. Presence of any other co morbid conditions like Diabetes mellitus and other cardiovascular complications.
3. Participants having IUCD(Intra uterine contraceptive device).
4. Presence of Thrombocytopenic purpura, Coagulopathy and any other bleeding complications.
5. Presence of severe Anemia (<6 gm%)
6. Hypothyroidism
7. Pregnant or lactating women and with history of recent abortion.
8. Hypersensitivity to any of the components of the formulation.
9. Vulnerable population such as TB affected individuals, HIV and HBsAg positive patients.
10. Presence of any other condition that leads the investigator to conclude that the patient is inappropriate for inclusion in this clinical study.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Regularization of menstrual cycle and flow at the end of 12 weeks.
2. Normalization or reduction of fibroid in group 2 - findings in ultrasonography (reduction in fibroid size) at the end of 12 weeks compared to baseline.
3. Hormonal assay (LH, FSH, Estradiol & Progesterone) at the end of 12 weeks treatment in PCOS patients of group 1.
 		 baseline and end of 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor for any adverse events during the study period
[At end of 12 weeks (post study) of the study period, Complete blood count and Biochemical parameters will be repeated to assess the safety of the participants] and
Assess the quality of life using a pre-and post-feedback questionnaire.
 		 Baseline and end of 12 weeks 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   31/05/2020 
Date of Study Completion (India) 10/02/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Forty five study Participants will be randomized into 3 groups with 15 patients in each group.

Group 1: Patients with Menstrual irregularities(mild to moderate) with PCOS will receive Syp. Femigard gold 15 ml orally twice daily for 12 weeks.
Group 2: Patients with Menstrual irregularities(mild to moderate) with Fibroid will receive Syp. Femigard gold 15 ml orally twice daily for 12 weeks.
Group 3: Patients with Menstrual irregularities(mild to moderate) without any underlying Uterine pathology will receive Syp. Femigard gold 15 ml orally twice daily for 12 weeks.
The outcome measures monitored are: 

1. Regularization of menstrual cycle and flow at the end of 12 weeks.

2. Normalization or reduction of fibroid in group 2 - findings in ultrasonography (reduction in fibroid size) at the end of 12 weeks compared to baseline.

3. Hormonal assay (LH, FSH, Estradiol & Progesterone) at the end of 12 weeks treatment in PCOS patients of group 1.

 
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