| CTRI Number |
CTRI/2025/05/086928 [Registered on: 14/05/2025] Trial Registered Prospectively |
| Last Modified On: |
13/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
An interventional study to evaluate the effect of shankupushppi choornam in premenstrual syndrome in participants with age group of 20-40 years. |
|
Scientific Title of Study
|
Effectiveness of Shankhapushpi churna in 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 |
DrAiswarya Preman UV |
| Designation |
PG Scholar, Department of Prasutitantra and Streeroga |
| Affiliation |
Government Ayurveda college Thiruvananthapuram |
| Address |
Room no 2, Dept. of prasootitantra and streeroga Government Ayurveda Medical college.
Thiruvananthapuram
Kerala
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9496785280 |
| Fax |
|
| Email |
aiswaryamalu13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAiswarya Preman UV |
| Designation |
PG Scholar, Department of Prasutitantra and Streeroga |
| Affiliation |
Government Ayurveda college Thiruvananthapuram |
| Address |
Room no 2, Dept. of prasootitantra and streeroga Government Ayurveda Medical college.
Thiruvananthapuram
Kerala
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9496785280 |
| Fax |
|
| Email |
aiswaryamalu13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Asha Sreedhar |
| Designation |
Professor and HOD Department of Prasutitantra and Streeroga |
| Affiliation |
Government Ayurveda Medical college and Hospital Pariyaram Kannur |
| Address |
Room no 2, Dept. of prasootitantra and streeroga Government Ayurveda Medical college.
Thiruvananthapuram
Kerala
Kannur
KERALA
670503
India |
| Phone |
9447893112 |
| Fax |
|
| Email |
drashaajith@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda Medical College and Hospital Thiruvananthapuram |
|
|
Primary Sponsor
|
| Name |
Dr Aiswarya Preman UV |
| Address |
PG Scholar Government Ayurveda Medical college and Hospital Thiruvananthapuram |
| 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 Aiswarya Preman UV |
Govt Ayurveda college Hospital for Women and Children Poojappura Thiruvananthapuram |
Dept of Prasutitantra and Streeroga OP no-2, Govt Ayurveda college,Thiruvananthapuram
Thiruvananthapuram
KERALA |
9496785280
aiswaryamalu13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee (IEC)Government Ayurveda College,Thiruvananthapuram,Kerala,India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F59||Unspecified behavioral syndromes associated with physiological disturbances and physical factors. Ayurveda Condition: PMS, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: shankupushppi churna, Reference: charaka samhita chikitsa sthana rasayana adyaya karaprachitheeya pada, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: milk), Additional Information: -nil |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Participants whose menstrual cycle is regular with a duration of 2-6 days and 28 days of interval. Participants who are competent and willing to give written consent. Participants of age group 20-40 years diagnosed as Premenstrual syndrome using ACOG criteria with score 40 or above assessed by Premenstrual syndrome scale.
|
|
| ExclusionCriteria |
| Details |
Participants undergoing prolonged medication for uncontrolled and chronic systemic illness. Participants with mood disturbances or any other psychiatric disorder. Participants with menopausal syndrome. Participants who are taking oral contraceptives and hormonal preparations. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in the score of Premenstrual symptoms assessed by premenstrual syndrome scale |
0th day ,31st and 61st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="23"
Sample Size from India="23"
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 4 |
|
Date of First Enrollment (India)
|
25/05/2025 |
| 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="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
|
Premenstrual syndrome refers to regular monthly experience of physiological and emotional distress in women of reproductive age, usually during several days preceding menses. This syndrome is typically characterized by nervousness, depression, fluid retention. The premenstrual syndromes become typically obvious during the luteal phase of the menstrual cycle.In ayurveda this stage is correlates to Rituvyateetakala during which Pithakopa and vata sanchayam occurs. Shankhapushpi churna is Seeta veerya and Madhura vipaka hence it is vata pitta samana in nature. The objective of the study is to find the effect of Shankhapushpi churna in Premenstrual Syndrome. The study design will be interventional study pre and post test with a sample size of 23. Females of age group 20-40 years attending the out-patient department of prasutitantra and Streeroga, fulfilling the American College of Obstetrics and Gynecology criteria (ACOG) of Premenstrual syndrome will be selected for the study. Study tool includes ACOG criteria, Case proforma, and symptom assessment by Premenstrual syndrome premenstrual syndrome score scale. Shankhapushpi churna will be given in a dose of 6gm with 30 ml of milk twice daily after food. Administration of drug will be starting starting from 10th day of menstruation for 14 days in 2 consecutive menstrual cycles. Participants will be assessed on 0th day, 31 day and on 61st day during the study period. Result will be analyzed statistically and summarized to arrive at conclusions. |