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CTRI Number  CTRI/2020/06/026204 [Registered on: 29/06/2020] Trial Registered Prospectively
Last Modified On: 01/12/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Use of Releeva 5 in menstrual irregularity 
Scientific Title of Study   A Randomized, Open Label, Multicentered, Parallel Group Clinical Study To Evaluate The Efficacy And Safety of RELEEVA 5 Cramp Relief Herbal Tea, Roll-On Oil And Tablets In The Management Of Primary Dysmenorrhea and Premenstrual Syndrome.  
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

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

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

Chennai
TAMIL NADU
Dr Ramesh kannan
India 
Phone  7708925866  
Fax    
Email  srkguruvarshan@gmail.com  
 
Source of Monetary or Material Support  
Tirupati Life Sciences Surajpur, Nahan Road, Paonta Sahib, Disst. Sirmour, Puruwala Santokhgarh, Himachal Pradesh 173025  
 
Primary Sponsor  
Name  Tirupati Life Sciences 
Address  Surajpur, Nahan Road, Paonta Sahib, Disst. Sirmour, Puruwala Santokhgarh, Himachal Pradesh 173025 
Type of Sponsor  Pharmaceutical industry-Global 
 
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 Ramesh Kannan  PM Medical Centre  Room no:10, Dept. of Medicine, OPD, PM Medical Centre, Wallajapet, Ranipet, Tamil Nadu.
Vellore
TAMIL NADU 		 7708925866

srkguruvarshan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ki3  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Notified 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N944||Primary dysmenorrhea,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Releeva 5 cramp relief Roll-on oil. Boswellia serrata 150 mg with camphor, menthol, clove oil and eucalyptus oil.  Apply the roll-on oil(4 rolls- Boswellia serrata 150 mg) on the pain affected lower abdomen, thigh and lower back. Applied 4 times daily, for a period of 5 days of menstrual cycle.  
Intervention  Releeva 5 Herbal Tea Granules Lodhra & Lajjalu each 250 mg with ginger, fenugreek and green tea & chamomile  Take fresh water & allow it to boil and Add entire sachet(5 gm) in 90ml of hot water and mix Drink twice in a day, for a period of 5 days of menstrual cycle  
Intervention  Releeva 5 premenstrual syndrome tablets. Chamomile, fenugreek, ginger each 75 mg, with chastebery, myoinositol, vitamin b 1, vitamin b 6 and black cohosh root.  Take one tablet of the FDC thrice daily 3 days before menses  
Comparator Agent  Tablet Mefenamic acid 250mg with Dicyclomine Hydrochloride 10mg (MEFTAL-SPAS)   One tablet(250 mg + 10 mg FDC ) taken orally 2 times daily after food, for a period of 5 days of menstrual cycle 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. Female participants between the age of 18-45 years (both inclusive) with regular menstrual cycles (21–35 days)
who are clinically diagnosed to have primary dysmenorrhea.
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. Participants who are willing to give written, signed and dated informed consent to participate in the study.
 
 
ExclusionCriteria 
Details  1. Secondary dysmenorrhea
2. Presence of any other Gynaecological diseases.
3. Pregnant or breastfeeding or planning to become pregnant during the study period.
4. Known case of Hypersensitivity to Investigational drug content.
5. Patients suffering from abnormal haematological or biochemical (renal & liver function) blood parameters.
6. Received any other investigational medicine within 7 days prior to screening which can interfere with investigational product activity
7. Suffering from any illness which will interfere with present study as decided by clinical investigator
8. Any condition decided as unfit for study by Clinical investigator
 
 
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. Change from baseline in menstrual pain intensity measured by Pain VAS Scale (0-10)
2. Changes in clinical global impression scale(CGI)
3. Changes from base line in following laboratory parameter(s):
Prostaglandin (PGF2α), Hs-C Reactive Protein, ESR, Serum fibrinogen and Complete Blood Count
 		 Day 1 to day 5 
 
Secondary Outcome  
Outcome  TimePoints 
4. Changes from base line in Quality of life- Questionnaires (Short Form Health-12 or 36), Systemic symptoms (VMS)
5. Duration of pain relief in hours (After medication)
6. Change in the Pre-menstrual syndrome assessment questionnaire
Adverse events and serious adverse events during the study period  		 Day 1 to day 5 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   30/06/2020 
Date of Study Completion (India) 27/11/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
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   A total of 90 female study participants who are clinically diagnosed to have primary dysmenorrhea will be included in the study. The selection of the patients will be based on initial screening and study criteria.

      Group 1- Participants with Primary dysmenorrhea will take one tablet of Releeva 5 premenstrual syndrome tablet orally thrice daily 3 days before menses followed by Releeva 5 Herbal Tea Granules extract  twice daily for a period of 5 days during the menstrual cycle.

      Group 2 -  Participants with Primary dysmenorrhea will take one tablet of Releeva 5 premenstrual syndrome tablet orally thrice daily 3 days before menses followed by topical application of Releeva 5 cramp relief Roll-on oil on the pain affected lower abdomen, thigh and lower back four times daily for a period of 5 days during the menstrual cycle.

     Group 3 - Participants with Primary dysmenorrhea will take tablet MEFTAL-SPAS orally 2 times daily for a period of 5 days during the menstrual cycle.

      The primary and secondary outcome measures will be monitored over a period of 5 days and follow up for 1 month.


 
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