| CTRI Number |
CTRI/2023/10/058629 [Registered on: 13/10/2023] Trial Registered Prospectively |
| Last Modified On: |
09/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to Evaluate the safety and efficacy of Navroop- DS in patients suffering from Oligomenorrhea. |
|
Scientific Title of Study
|
Open Label, Single Arm Clinical Study to Evaluate the safety and efficacy of Navroop- DS in patients suffering from Oligomenorrhea. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MGCTS/20/119 Version 1.0 Dated 11 Jul 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raakhi Mehra |
| Designation |
Principal Investigator |
| Affiliation |
GS Ayurveda Medical College & Hospital Pilkhuwa Hapur |
| Address |
Ground floor, room no.2, Dept of General Medicine
GS Ayurveda Medical College & Hospital Pilkhuwa Hapur.
Meerut
UTTAR PRADESH
250002
India |
| Phone |
9868965688 |
| Fax |
|
| Email |
raakhimehra49@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
MGCTS(Mittal Global Clinical Trial Services) |
| Address |
First Floor, Room 4, Clinical Research Dept, Mittal Building,
Mansarovar Ind Estate, Panchli Khurd, Baghpat Road Meerut
Meerut
UTTAR PRADESH
250002
India
Meerut
UTTAR PRADESH
250002
India |
| Phone |
8937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
Details of Contact Person
Public Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
MGCTS(Mittal Global Clinical Trial Services) |
| Address |
First Floor, Room 4, Clinical Research Dept, Mittal Building,
Mansarovar Ind Estate, Panchli Khurd, Baghpat Road Meerut
Meerut
UTTAR PRADESH
250002
India
Meerut
UTTAR PRADESH
250002
India |
| Phone |
8937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
|
Source of Monetary or Material Support
|
| Ambic Ayurved India Pvt. Ltd.
Kunda Road, I.E Partapur, U.P Meerut- 250103 |
|
|
Primary Sponsor
|
| Name |
Ambic Ayurved India Pvt. Ltd. |
| Address |
Kunda Road, I.E Partapur, U.P Meerut- 250103 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Raakhi Mehra |
GS Ayurveda Medical College & Hospital |
Ground floor, room no.2, Dept of General Medicine
GS Ayurveda Medical College & Hospital Pilkhuwa Hapur.
Meerut
UTTAR PRADESH |
9868965688
raakhimehra49@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GS Ayurveda Medical College & Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N915||Oligomenorrhea, unspecified. Ayurveda Condition: ARTAVAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Navroop DS Syrup, Reference: NA, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Females from 18 to 45 years of age.
2. Females suffering from Oligomenorrhea.
3. If female with childbearing potential, must be willing to practice an acceptable form of birth control for the duration of the study.
4. Females that are able to give written informed consent in a manner approved by the institutional ethics committee and comply with the requirements of the study.
5. Females willing to avoid participation in any other interventional clinical trial for the duration of the study. |
|
| ExclusionCriteria |
| Details |
1. Females that are pregnant, breast feeding, or planning to get pregnant during the study.
2. Females that have participated in any other interventional clinical trial in the previous 90 days.
3. Females with known sensitivity to any of the constituents of the investigational product. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Efficacy:
•Change in the SGA Score (0-3) [Time frame 0-90 days] calculated as Abdominal Cramp, Headache, Vaginal discharge, Bloating, Irritability, Mood swings.
•Change in the LH range within time frame 0-90 days.
•Change in the FSH range within time frame 0-90 days.
•Change in the LH/FSH Ratio range within time frame 0-90 days.
Safety:
•Adverse Events
Tolerability of Navroop-DS syrup and tablet in treatment of Oligomenorrhea.
|
[Time frame 0-90 days] |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| •Improvement in Quality of Life(SF-36) |
[Time frame 0-90 days] |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
20/10/2023 |
| 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="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a phase PMCF single-arm, open label trial to evaluate the efficacy of Navroop- DS Syrup and Tablet when administered up to 90 days to the females suffering from Oligomenorrhea from age 18 years to 45 years of age.The trial subjects will be enrolled at 1 investigative site in India with approximately 40 patients who meet the trial inclusion and Exclusion criteria. Subjects will be on study for up to 90 days. Screening and Baseline: Day 1 Physical Follow-up: Day 30 Physical Follow-up: Day 60 End Visit: Day 90 |