FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/04/041911 [Registered on: 19/04/2022] Trial Registered Prospectively
Last Modified On: 01/04/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Ayurvedic Treatment for Primary Dysmenorrhea Kashtartava 
Scientific Title of Study   COMPARATIVE CLINICAL STUDY OF MENOCRAMP TABLET AND SAPTASARAM GHAN VATI IN THE MANAGEMENT OF KASHTARATVA (PRIMARY DYSMENORRHEA) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nidhi Sharma 
Designation  PG Scholar 
Affiliation  Parul Institute of Ayurveda, Parul University 
Address  309 Department of PTSR Parul Institute of Ayurveda P O Limda Tal Waghodia

Vadodara
GUJARAT
391760
India 
Phone  9915851262  
Fax  02668-260201  
Email  drnid31@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Asokan V 
Designation  Professor 
Affiliation  Parul Institute of Ayurveda, Parul University 
Address  309 Department of PTSR Parul Institute of Ayurved P O Limda Tal Waghodia

Vadodara
GUJARAT
391760
India 
Phone  6361740431  
Fax  02668-260201  
Email  drasokan24@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Asokan V 
Designation  Professor 
Affiliation  Parul Institute of Ayurveda, Parul University 
Address  309 Department of PTSR Parul Institute of Ayurved P O Limda Tal Waghodia

Vadodara
GUJARAT
391760
India 
Phone  6361740431  
Fax  02668-260201  
Email  drasokan24@gmail.com  
 
Source of Monetary or Material Support  
Soulmiks Herbaceuticals Limited  
 
Primary Sponsor  
Name  Solumiks Herbaceuticals Limited  
Address  135 Nanubhai Desai Road Khetwadi Mumbai 400004 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NA   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nidhi Sharma  Teaching Hospital of Parul Ayurveda Hospital  Room no 104 OPD of Department of PTSR Parul Institute of Ayurveda Parul University PO Limda Tal Waghodia
Vadodara
GUJARAT 
9915851262
02668-260201
drnid31@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee PIA PU  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N944||Primary dysmenorrhea. Ayurveda Condition: UDAVARTINI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Saptasaram Kwath Ghan Vati , Reference: Sahasra Yoga Kasahya Prakarana 284 , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: 5 days in a month during menstrual phase
2Comparator ArmDrugOther than Classical(1) Medicine Name: Menocramp tablets, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: 5 days in a month during menstrual period
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  30.00 Year(s)
Gender  Female 
Details  1. Women between the age group 15 to 30 years.

2. Women with regular cycle with painful menstruation.
3. Women without any pelvic pathology.

4. Be able and willing in the view of the investigator to comply with all study procedures and sign informed written consent form.
 
 
ExclusionCriteria 
Details  Women with history of PID endometriosis and debilitating pathological conditions of the pelvic organs, systemic diseases like diabetes mellitus bronchial asthma tuberculosis thyroid dysfunction with organic lesion benign or malignant growth of reproductive tract uterine prolapse and Hypo-plastic uterus
Women with congenital anomalies of genital organs
Polycystic ovarian disease
Patients with chronic hepatic neurological or orthopedic conditions neuropsychiatric illness malignancy or AIDS
Subjects rejecting to sign the consent form drug addicts
Patients with clinically significant cardiovascular, hematological, pancreatic metabolic neurological disorders or clinically significant laboratory abnormalities which in the judgement of the investigator would interfere with the subjects participation in the study or evaluation of the subjects response to therapy


 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
pain relief
relief in associated complaints  
1 month with 1 month follow up  
 
Secondary Outcome  
Outcome  TimePoints 
psychological relief and improvement in QoL of participants   1 month during study and during follow up period 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   25/04/2022 
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   In our society women is compared to mother earth as both have the quality of forbearance and procreation. 
Dysmenorrhea is a medical condition of painful menstruation of sufficient magnitude so as to incapacitate day to day activities . 
The prevalence rate of dysmenorrhea in adolescent girls is 70.2% in india.
According to Acharaya Sushruta , pain is indication of vata vikruti.

Ø  Majority of previous works carried out were either based on procedure like Uttarbasti or were based on basti. Since it is impossible for uttar basti to be performed on unmarried patients, and also the young those hesitate to undergo Matra Basti who are the most sufferers. Only few works have been done on oral form of medicine for the treatment of Kashtartava.

Ø  Till date, no successful advances have been made in the management of Primary dysmenorrhea by conventional medicine. The best evidence-based treatments are NSAIDs and hormonal contraceptives but they have a lot of side effect.

Ø  According to Ayurveda, pain is an indication of Vata Vikriti. Vitiated Apana Vata is considered as the primary cause for Yoni vikara’s. Hence, all measures capable of suppressing Vata are indicated.

 AIM:

The present study has been planned to accomplish following aims and objective:

·       To evaluate and compare the efficacy of “Saptasaram ghan vati” with Menocramp tablets in the management of Kashtartava.

 

OBJECTIVE:

·       To evaluate the effect of drug on associate complaints of dysmenorrhoea. 

·       To assess the efficacy of drug in reducing the psychological complaints associated with dysmenorrhoea.

HYPOTHESIS:

·       Null Hypothesis (H0): Saptasaram ghan vati is not effective in the management of Kashtartava when compared to Menocramp tablets.

·       Alternate Hypothesis (H1): Saptasaram ghan vati is more effective in the management of Kashtartava when compared to Menocramp tablets.


Diagnostic Criteria:

·       Painful menstruation of acute and spasmodic nature

·       Pain of sufficient magnitude to hamper the routine daily activities for 48 - 72 hours duration in regular menstrual cycles.

·       Associated with or without constipation, loose stools, nausea, breast tenderness, mood swings, headache, giddiness, irritability.

 

Study Duration:

·       1 menstrual cycle

·       Medicine will be given from first day of menses till 5th day of menses for one cycle

·       Follow up for next one menstrual cycle without medicine for both groups.

 

Assessment of Pain (Dysmenorrhea):

VISUAL ANALOGUE SCALE

NO PAIN

(0)

ANNOYING (MILD)

(2 TO 3)

UNCOMFORTABLE

(MODERATE) (4 TO 6)

HORRIBLE

(SEVERE) (7 to 9)

WORST (10 )

 

WaLIDD SCORE VARIABLE

Working ability

Location

Intensity

Days of Pain

0 None

0 None

0 Does not Hurt

0 Zero

1 Almost never

1 one site

1 Hurts a little bit

1 One- Two

2 Almost always

2 two – three sites

2 Hurts a little more- hurts even more

2 Three- Four

3 Always

3 four sites

3 Hurts a whole lot – hurts worst

3 >Five

 

Notes: Score 0 without Dysmenorrhea, 1- 4 mild Dysmenorrhea, 5-7 moderate Dysmenorrhea, 8-12 severe Dysmenorrhea.


 
Close