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CTRI Number  CTRI/2021/07/034539 [Registered on: 02/07/2021] Trial Registered Prospectively
Last Modified On: 04/10/2021
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A Single Centric, Open Label, Non-Randomized, Phase IV Post Marketing Surveillance Study to Evaluate the Efficacy and Safety of Product Sachi Saheli in order to improve the quality of life during the menstruation cycle  
Scientific Title of Study   A Single Centric, Open Label, Non-Randomized, Phase IV Post Marketing Surveillance Study to Evaluate the Efficacy and Safety of Product Sachi Saheli in order to improve the quality of life during the menstruation cycle in female subjects of 13 to 45 years of age 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Radhika Kamuni S 
Designation  MBBS, DGO, DNB 
Affiliation  SARV Advanced Multispeciality Clinic and Diagnostic Centre 
Address  SARV Advanced Multispeciality Clinic and Diagnostic Centre SLV Complex, Dasarahalli main road, Malleshpalya, New Tippasandra, Bangalore-560075

Bangalore
KARNATAKA
560075
India 
Phone  8884393281  
Fax    
Email  drradhikakm@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vijay Kimtata 
Designation  Scientific Medical Reviewer 
Affiliation  Divisa Herbal Care 
Address  SCO 135-136, 2nd Floor, Sector 9 C, Above CM automobiles, Near CITCO Petrol Pump, Madhya Marg, Chandigarh-160009, India

Chandigarh
CHANDIGARH
160009
India 
Phone  9816333352  
Fax    
Email  vijaykimtata.vk@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mr Hasan Ali Ahmed 
Designation  Director 
Affiliation  Xplora Clinical Research Services Pvt. Ltd 
Address  #252, 13th cross, Wilson Garden, Bangalore-560027

Bangalore
KARNATAKA
560027
India 
Phone  9886012598  
Fax    
Email  hasan@xplorahealth.com  
 
Source of Monetary or Material Support  
Divisa Herbal Care SCO 135-136, 2nd Floor, Sector 9 C, Above Automobiles, Near CITCO Petrol Pump, Madhya Marg, Chandigarh-160009, India 
 
Primary Sponsor  
Name  Divisa Herbal Care 
Address  SCO 135-136, 2nd Floor, Sector 9 C, Above CM Automobiles, Near CITCO Petrol Pump, Madhya Marg, Chandigarh-160009, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Radhika Kamuni S  SARV Advanced Multispeciality Clinic and Diagnostic Centre  SLV Complex, Dasarahalli Main Road, Malleshpalya, New Tippasandra, Bangalore - 560075
Bangalore
KARNATAKA 		 8884393281

drradhikakm@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACE Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N946||Dysmenorrhea, unspecified. Ayurveda Condition: Menstruation Cycle,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  Sachi Saheli  Oral administration of 10 ml syrup twice a day after meal, preferably morning and evening. 1 tablet twice a day orally after meal, preferably morning and evening 
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. Age between 13 to 45 (Female subjects only)
2. Subjects suffering from Dysmenorrhea and/or Leucorrhea
3. Willingness to take part in study and able to attend all scheduled visits
4. Subjects suffering from issues like loss of appetite, anemia, general weakness and period irregularities
 
 
ExclusionCriteria 
Details  1. Pregnant, breast-feeding, subjects undergone any surgery and else taken part in any clinical trial
2. Not willing to sign the ICF or give the consent
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To evaluate the increase in blood hemoglobin level in female subjects as compared to baseline.
2. To determine the total number of subjects with symptomatic relief of lower back pain, leucorrhea and general weakness assessed through Investigator Assessment Questionnaire and Subjective Assessment Questionnaires.

 		 Day 1- day 90
 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess the safety of investigational product Sachi Saheli.
2. Incidence of adverse events reported or observed during the study period.
 		 Day 1-day 90 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   15/07/2021 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   Not Yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
The study is a single centric, open label, Non-randomized, Phase IV Post marketing surveillance study on 120 subjects. There are four visits in the study with one being telephonic follow-up. On screening visit i.e., Day 0, the subjects will be screened based on inclusion and exclusion criteria. An informed consent/assent form will be given to all subjects/parent at the screening visit containing all study information in it. Eligible subjects will be enrolled into the study after the informed consent procedure and laboratory investigations reports. Blood will be withdrawn for laboratory investigations (CBC, ESR, Serum Creatinine & SGPT) on Day 0 and Day 90. Investigator will explain the subject about all study-related procedures, the telephonic follow-up on Day 45 (Visit 3) and end of study on Day 90 (Visit 4). All eligible subjects will be then provided with IP - Sachi Saheli syrup and tablets by investigator/study co-ordinator on Day 1 (Visit 2). The instructions will be given to the subject to use the IP at home from Day 1 to Day 90 i.e., Take 10 ml of Sachi Saheli syrup twice daily after meal, preferably morning and night and 1 tablet twice a day orally after meal, preferably morning and night. An Investigator Assessment Questionnaire and Subjective Assessment Quality of Life Questionnaire will be performed on Day 0 and Day 90 to evaluate the efficacy of IP- Sachi Saheli Syrup and Tablet.
 
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