| CTRI Number |
CTRI/2025/04/084141 [Registered on: 04/04/2025] Trial Registered Prospectively |
| Last Modified On: |
03/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Shweta jeeraka in the management of Premenstrual syndrome. |
|
Scientific Title of Study
|
A randomized placebo controlled clinical study to evaluate the efficacy of Shweta jeeraka (Cuminum cyminum Linn.) in the management of Premenstrual 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 Anusha Anant Hegde |
| Designation |
PG scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research College and Hospital, Bangalore |
| Address |
Room number 104, Dept of PG Studies in Dravyaguna Sri Sri College of
Ayurvedic Science and Research Hospital 21st Km Kanakapura Road,Udayapura PO-OB Chudahalli, Bangalore, karnataka
560082 India
Bangalore
KARNATAKA
560082
India |
| Phone |
07019687304 |
| Fax |
|
| Email |
anushaah23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Pradeep |
| Designation |
HOD and professor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research College and Hospital, Bangalore |
| Address |
Dept of PG Studies in Dravyaguna Sri Sri College of
Ayurvedic Science and Research Hospital 21st Km Kanakapura Road,Udayapura PO-OB Chudahalli, Bangalore, karnataka
560082 India
Bangalore
KARNATAKA
560082
India |
| Phone |
9448330936 |
| Fax |
|
| Email |
ayurseema@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Seema Pradeep |
| Designation |
HOD and professor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research College and Hospital, Bangalore |
| Address |
Dept of PG Studies in Dravyaguna Sri Sri College of
Ayurvedic Science and Research Hospital 21st Km Kanakapura Road,Udayapura PO-OB Chudahalli, Bangalore, karnataka
560082 India
Bangalore
KARNATAKA
560082
India |
| Phone |
9448330936 |
| Fax |
|
| Email |
ayurseema@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of
Ayurvedic Science and Research Hospital 21st Km Kanakapura Road,Udayapura PO,Bangalore, karnataka
560082 India |
|
|
Primary Sponsor
|
| Name |
Dr Anusha Anant Hegde |
| Address |
Room number 104, Dept of PG Studies in Dravyaguna Sri Sri College of
Ayurvedic Science and Research Hospital 21st Km Kanakapura Road,Udayapura PO-OB Chudahalli, Bangalore, karnataka
560082 India |
| Type of Sponsor |
Other [self] |
|
|
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 Anusha Anant Hegde |
Sri Sri College of Ayurvedic Science and Research College and Hospital, Bangalore |
Room number 104, KC3 OPD, Department of dravyaguna,Sri Sri College of
Ayurvedic Science and Research Hospital 21st Km Kanakapura Road,Udayapura PO-OB Chudahalli, Bangalore, karnataka
560082 India
Bangalore
KARNATAKA |
07019687304
anushaah23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sri Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N943||Premenstrual tension syndrome. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shweta jeeraka (Cuminum cyminum Linn.), Reference: Bhvaprakasha nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: warm water), Additional Information: -1gm of shweta jeeraka (Cuminum cyminum Linn.) thrice a day in capsular form
- duration- 2 weeks prior to expected date of menstruation for 3 consecutive cycles | | 2 | Comparator Arm (Non Ayurveda) | | - | Placebo | 1gm of starch thrice a day in capsular form, before food with water
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Subjects between age group of 20 to 40 years, irrespective of their marital status.
2.Subjects presenting with mild to moderate symptoms of Premenstrual syndrome (PMS) with regular menstrual cycle.
3.Subjects who are willing to give written consent for the study.
|
|
| ExclusionCriteria |
| Details |
1.Subjects with irregular menstruation.
2.Subjects undergoing hormone therapy.
3.Subjects under alcohol use or any other substance abuse.
4.Subjects exhibiting symptoms continuous throughout the phase of menstrual cycle.
5. Subjects with underlying pathological conditions of breast and pelvis.
6. Subjects with Premenstrual Dysphoric Disorder (PMDD) and any pre-existing psychological disorder.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Significant improvement in the symptoms of Premenstrual syndrome.
|
1st assessment (BT)- 0th day
2nd assessment -5th day of the first cycle
3rd assessment - 5th day of the second cycle
4th assessment- 5th day of the third cycle
5th assessment (drug free)- 5th day of the fourth cycle
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in quality of life
Generation of in-depth analysed data on the different aspects of the disease.
Generation of data on possible adverse drug reaction.
|
1st assessment (BT)- 0th day
2nd assessment -5th day of the first cycle
3rd assessment - 5th day of the second cycle
4th assessment- 5th day of the third cycle
5th assessment (drug free)- 5th day of the fourth cycle
|
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/04/2025 |
| 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="3"
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
|
Premenstrual syndrome, a common cyclic disorder of young and middle aged women, is characterized by emotional and physical symptoms that consistently occur during the luteal phase of the menstrual cycle. It is a complex cluster of symptoms that occur 7 to 14 days prior to menses and ends after the onset of menses. The WHO International classification of diseases (ICD - 11) includes premenstrual tension syndrome under the heading diseases of genitourinary tract. It is also known as Premenstrual tension (PMT) and premenstrual stress. The pooled prevalence of reproductive age women affected with PMS worldwide amounts to 47.8%. Among these, about 20% of women experience symptoms severe enough to disrupt their daily activities, and the remaining have mild to moderate symptoms and Prevalence rate of PMS in India as obtained from the total 25 studies conducted between 2000 to 2020 is around 43%. Though the PMS is of unknown aetiology, there are theories stating to be influenced by several factors like stress, improper diet and lifestyele. The management of Premenstrual Syndrome (PMS) often involves a combination of pyridoxine (vitamin B6), hormonal treatments, and antidepressants. While these can be effective, they may also lead to side effects such as peripheral neuropathy, nausea, insomnia and early menopause. Symptoms of premenstrual syndrome are irritability, anxiety, mood swings, tearfulness, breast tenderness and bloating of abdomen. Shweta Jeeraka (Cuminum cyminum Linn.) is one of the important drug mentioned in Ayurveda classics which has the properties like Medhya, Hridya, Garbhashaya Vishodhaka and Adhmanahara. It is also a spice commonly used in the Indian kitchen, well known for its action in various diseases like indigestion, diarrhoea and gynaecological diseases. Considering the above properties, it is worthwhile to evaluate the efficacy of Shweta Jeeraka (Cuminum cyminum Linn.) in the management of Premenstrual syndrome.
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