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CTRI Number  CTRI/2018/03/012629 [Registered on: 19/03/2018] Trial Registered Retrospectively
Last Modified On: 11/02/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Clinical Evaluation of Safety & efficacy of Mensta (WHS/2004/1) in Menstural Cramps.  
Scientific Title of Study   Open clinical trial to evaluate the efficacy of WHS/2004/1 in Dysmenorrhoea & 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 Sudamini Choudhary  
Designation  Professor & Head of Department 
Affiliation  R.A Podar Ayurvedic Medical College & Hospital 
Address  Department of Stree Roga & Prasuti Tantra, R.A Podar Ayurvedic Medical College & Hospital, Worli

Mumbai
MAHARASHTRA
400018
India 
Phone  9224173659  
Fax  9224173659  
Email  csoudamini@yahoo.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Arun Gupta 
Designation  Head Medical Affairs & Clinical Research 
Affiliation  Dabur India Limited 
Address  Dabur Research & Development Centre Dabur India Limited Plot No.22,Site IV Sahibabad-

Ghaziabad
UTTAR PRADESH
201010
India 
Phone  9910200255  
Fax  01204552645  
Email  arun.gupta@dabur.com  
 
Details of Contact Person
Public Query  
Name  Dr Arun Gupta 
Designation  Head Medical Affairs & Clinical Research 
Affiliation  Dabur India Limited 
Address  Dabur Research & Development Centre Dabur India Limited Plot No.22,Site IV Sahibabad-

Ghaziabad
UTTAR PRADESH
201010
India 
Phone  9910200255  
Fax  01204552645  
Email  arun.gupta@dabur.com  
 
Source of Monetary or Material Support  
Dabur Research & Development Centre, Dabur India Ltd 22 site IV Sahibabad Ghaziabad 
 
Primary Sponsor  
Name  Dabur India Limited 
Address  Dabur Research and Development Centre Dabur India Limited Plot No.22 Site IV Sahibabad, Ghaziabad  
Type of Sponsor  Other [FMCG] 
 
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 Sudamini Choudhary  R. A Podar Ayurvedic Medical College & Hospital  Department of Stree Roga & Prasuti Tantra.
Mumbai
MAHARASHTRA 		 9224173659
9224173659
csoudamini@yahoo.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, R.A Podar Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N945||Secondary dysmenorrhea,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dabur Mensta (WHS/2004/1)  Studied formulation is composed of Saracs Indica, Santlllum album, Woodford/a frutlcoa, Trlphtla, Zingiber officinale, Mangifera indica, Cyperus rotundus, Cuminum cyminum, Adhatoda vasika, Berberis aristata, Piper longum, Nymphoea stellata, Operculina turpethum, Nigella sativa, Trachyspermum ammi, Ferula Foetida Regel, Aloe vera. The IP was administered at a dose of 10 ml b.i.d. 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. Patients aged between 15-45 years (females in the reproductive age group).
2. Females presenting with DYSMENORRHEA with or without any of the following
symptoms associated with menstruation
a. Any kind of pain like headache, backache abdominal pain,bodyache
b. Nausea and vomiting
c. Weakness
d. Psychological symptoms- like anxiety, stress, depression, irritability,
restlessness
e. Irregular cycles
3. Willingness to participate in the trial and to come for regular follow up as and when
required.
4. Readiness to sign Informed Consent Form 
 
ExclusionCriteria 
Details  1. Patients nursing or pregnant women.
2. Patients having organic causes of pain and menstrual abnormalities like uterine
myeloma, adenomyosis, polyps, fibroids, endometriosis etc.
3. Patients suffering from systemic or metabolic disorders like pituitary disease,
diabetes mellitus, thyroid dysfunction and coagulation-disorders.
4. Patients having any other kind of chronic disease like respiratory or cardiac
problems, HIV.
5. Subjects not willing to sign informed consent.
6. Patients participating in any other clinical study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Relief from symptoms of Dysmenorrhea  Evaluations were done at 2 week intervals for 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   N/A 
Date of First Enrollment (India)   09/08/2004 
Date of Study Completion (India) 26/01/2005 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Results of the study of this clinical study may be used for publishing scientific papers and data. All the data generated on the trial is exclusive property of sponsor; and no publication can be done without sponsor written approval 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
In the present study, the effect of a polyherbal preparation, Dabur Mensta, was studied on 50 women in the mean age group of 15-45 years suffering from dysmenorrhoea in an open label , prospective clinical study. The drug was administered through oral route at a dose of I0 ml b.i.d. for 12 weeks . On day 0 the subjects were evaluated and recruited in to the study after due consideration of the inclusion and exclusion criteria. Complete systemic examination is conducted and investigations are performed as desired.The treatment was continued for 12 weeks and thus covering minimum two cycles after the initiation of treatment. The treatment is stopped after 12 weeks and there were two follow-ups, every two weeks without treatment to observe the withdrawal after cessation of the trial drug treatment. After enrollment, all the subjects were given placebo syrup till the date of occurrence of the next cycle. Then treatment was started from 15th day of menstrual cycle. All the subjects were evaluated thereafter fortnightly (at 2 weekly intervals). In total 7 visits were planned for the period of 120 days. Difference in the mean VAS scores from baseline to end is analyzed to find out the efficacy of the trial drug. The treatment was continued for three cycles.
Results
The trial drug provided significant relief from all the five symptoms of dysmenorrhea. Pain abdomen and pain lower back are the two symptoms with maximum severity; Maximum relief on VAS score was achieved on Pain in abdomen 33.20 (41.50) & 29.00 (54.98%) respectively . Reduction of VAS scores in the other three symptom categories was also significant (P<0.05) . The drug also provided relief from incapacitation due to menstrual pain in all the
trial subjects. Majority of subjects reported with moderate to severe incapacitation at baseline viz ., 94 %. After the administration of the trial drug, this was reduced to 48% showing a reduction by 46%. These findings indicate the comprehensive effect of the trial drug on the symptoms of dysmenorrhea concluding the analgesic effect of the trial drug. The effect of the trial drug is cumulative and gradual in reducing effect on menstrual pain and incapacitation .
 
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