| CTRI Number |
CTRI/2024/06/068685 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
05/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical Study of polyherbal formulations for pre menstrual syndrome. |
|
Scientific Title of Study
|
Comparative Clinical Assessment of Two Polyherbal Formulations in Menstrual Health – A Proof of Concept |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr Pradip Kumar Panda |
| Designation |
Professor (Dean) |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital |
| Address |
Dean Room, Ground Floor, Sri Sri College of Ayurvedic Science and Research Hospital, Sri Sri University, Cuttack
Cuttack
ORISSA
754006
India |
| Phone |
9437150643 |
| Fax |
|
| Email |
deansscasrh@srisriuniversity.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Boblina Mohanty |
| Designation |
Sr. Gynecologist and Deputy Medical Superintendent |
| Affiliation |
Shisu Bhawan |
| Address |
Department of Gynaecology and Obstractics, Shisu Bhawan ( A branch of SCB Medical College). Cuttack.
Cuttack
ORISSA
753001
India |
| Phone |
9437164692 |
| Fax |
|
| Email |
drmohanty.og@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Baidyanath Mishra |
| Designation |
Head Healthcare Research |
| Affiliation |
Dabur India Limited |
| Address |
1st floor, Dabur Research and Development Centre, Dabur India limited, Plot no 22, Site 4, Sahibabad
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
911203378606 |
| Fax |
0120-4374935 |
| Email |
baidyanath.mishra@dabur.com |
|
|
Source of Monetary or Material Support
|
| Dabur Research and Development Centre, Dabur India limited, Plot no. 22, Site 4, Sahibabad, Ghaziabad, U.P.-201010 |
|
|
Primary Sponsor
|
| Name |
Dabur India Limited |
| Address |
Dabur Research and Development Centre, Dabur India Limited, Plot no 22, Site 4, Sahibabad |
| Type of Sponsor |
Other [Ayurveda Healthcare] |
|
|
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 |
| Prof Dr Pradeep Panda |
Sri Sri College of Ayurvedic Science and Research Hospital Department of Prasututantra and Streeroga |
Ground Floor, Department of Prasututantra and Streeroga, Sri Sri College of Ayurvedic Science and Research Hospital, Cuttack, ODISHA
Cuttack
ORISSA |
9437150643
deansscasrh@srisriuniversity.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) for Biomedical Research of Faculty of Health & Wellness, Sri Sri College of Ayurvedic Science and Research Hospital, Sri Sri university, Cuttack |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N943||Premenstrual tension syndrome. Ayurveda Condition: RUTUKALAH-RUTUMATIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: DRDC/2023/046, Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: DRDC/2023/042, Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 7(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: DRDC/2023/043, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: A polyherbal tablet |
|
|
|
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 PMS
3. Females with irregularity menstrual cycles (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 |
1. Subjects not willing to sign ICD.
2. Menopausal or peri-menopausal based on history
3. Currently pregnant or breastfeeding
4. Planning pregnancy in next 3-4 months
5. Not willing to practice birth control methods other than hormonal contraception (oral contraceptive pill) during the course of the trial.
6. Requirements of any prohibited concomitant medications (Oestrogen/Progesterone/ etc)
7. Gynaecological conditions like genital tuberculosis, history of any malignancy or organic lesions like polyps, fibroids, endometriosis etc. on USG
8. Prescence of chronic systemic conditions like endocrinal disorder like Cushing’s syndrome, hypertension, heart diseases, diabetes, hepatic disease, renal disease, or any psychiatric condition (medical history)
9. Subjects who in Investigators’ opinion will not be able to follow study related procedures.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Re-establishes cyclical bleeding.
• Controls excess bleeding occurring in the menstrual cycle.
• Relieves from backache, pelvic pain, abdominal cramps.
• Controls leucorrhoea
Improvement basis change in CGI scale
• Modification in Quality of Life (QoL) – includes fatigue, Mood swing, hot flushes on sole, restlessness, anxiety, irritability, bloating, food cravings, nausea, vomiting, diarrhoea/ constipation, headaches /joint pains etc (assessed by psychologist as per Annexure 2)
|
30, 60, 90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Improvement in PCV, and Hb%, glowing skin.
• Regularization of Menstrual Irregularities (oligomenorrhea, menorrhagia, Polymenorrhea, hypomenorrhea – DUB)
|
Pre and post treatment |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
12/07/2024 |
| 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 Yet Recruiting |
| 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
|
Current study is a comparative clinical study of two polyherbal formulations for menstrual health. Study will be conducted under supervision of Ayurvedic and Allopathic Doctors as investigator and co-investigators in subjects between 19 to 45 years of age and who will be followed up at monthly intervals. results of the study will be assessed basis regularization of menstruation, improvement in quality of life and PMS from baseline to end of study. |