| CTRI Number |
CTRI/2024/03/064639 [Registered on: 21/03/2024] Trial Registered Prospectively |
| Last Modified On: |
21/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical study of DMH Syrup and Tablets in Problems before Menstruation |
|
Scientific Title of Study
|
Clinical Assessment of DMH Syrup and DMH Tablets in Pre-menstrual Syndrome |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anupama V |
| Designation |
Professor |
| Affiliation |
Sri Kalabyraveshwara Swamy Ayurvedic Medical College And Research Centre Bangalore |
| Address |
Room No 210
Department of PTSR
No 10 Pipe Line Road Rpc Layout Vijayanagar Bangalore
Room No 209
Department of PTSR
No 10 Pipe Line Road Rpc Layout Vijayanagar Bangalore
Bangalore
KARNATAKA
560104
India |
| Phone |
9845442660 |
| Fax |
|
| Email |
dr.anupama.v@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anupama V |
| Designation |
Professor |
| Affiliation |
Sri Kalabyraveshwara Swamy Ayurvedic Medical College And Research Centre Bangalore |
| Address |
Room No 210,
Department of PTSR
No 10 Pipe Line Road Rpc Layout Vijayanagar Bangalore
Room No 209,
Dept of PTSR
No 10 Pipe Line Road Rpc Layout Vijayanagar Bangalore
Bangalore
KARNATAKA
560104
India |
| Phone |
9845442660 |
| Fax |
|
| Email |
dr.anupama.v@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anupama V |
| Designation |
Professor |
| Affiliation |
Sri Kalabyraveshwara Swamy Ayurvedic Medical College And Research Centre Bangalore |
| Address |
Room No 210
Dept of PTSR
No 10 Pipe Line Road Rpc Layout Vijayanagar Bangalore
Room No 209
Dept of PTSR
No 10 Pipe Line Road Rpc Layout Vijayanagar Bangalore
Bangalore
KARNATAKA
560104
India |
| Phone |
9845442660 |
| Fax |
|
| Email |
dr.anupama.v@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dabur India Ltd
8/3,Asaf ali road , New Delhi - 110002
INDIA |
|
|
Primary Sponsor
|
| Name |
Dabur India Ltd |
| Address |
Plot No 22 Site IV Sahibabad Ghaziabad 201010 UP India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR Anupama V |
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Center |
Room No 209
Dept of PTSR
No 10 Pipe Line Road Rpc Layout Vijayanagar Bangalore
Bangalore
KARNATAKA |
9845442660
r.anupama.v@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee SKAMCH & RC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F322||Major depressive disorder, singleepisode, severe without psychotic features. Ayurveda Condition: ARTAVAVAHASROTOVIKARAH, (2) ICD-10 Condition:N943||Premenstrual tension syndrome. Ayurveda Condition: ARTAVADOSHAH/ARTAVADUSHTIH/RAJODOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: DMH Tablet, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: water), Additional Information: - | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: DMH SYRUP, Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Provision of signed and dated informed consent prior to any study-specific procedures.
2. Healthy females in the age group of 19-45 years with a history of psychological or somatic signs and symptoms of Pre-menstrual syndrome (PMS)
3. Females with regular menstrual cycles of 21-35 days (based on history)
4. Not on any hormonal therapy during and one month prior to the trial. 5. Willing to practice birth control methods other than hormonal contraception (barrier/condoms) during study period (as applicable)
6. Willing to follow study related procedures.
|
|
| ExclusionCriteria |
| Details |
Gynaecological conditions like history of any malignancy or organic lesions like genital tuberculosis, polyps, fibroids, endometriosis etc.Patients presenting with irregular menstrual cycle.Currently pregnant or breastfeeding.Planning pregnancy in next 3-4 months.Not willing to practice birth control methods other than hormonal contraception (oral contraceptive pill) during the course of the trial.Requirements of any prohibited concomitant medications (Oestrogen/Progesterone/ etc)
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in psychological and somatic symptoms of premenstrual syndrome like Irritability, Mood swings, Periodic cramps after the administration of DMH syrup and DMH tablet after 90 days |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the impact of DMH syrup & tablet on change in Qol of women with Pre-menstrual syndrome
Improvement in lab parameters like CBC (ESR), Hormonal Levels & Urinalysis (assessed from Baseline to End of Study)
Safety assessment basis adverse event reporting & løb parameters (LFT & RFT)
o assess palatability & tolerability of products after 90 days of intervention |
90 days |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="30"
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)
|
15/04/2024 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
|