| CTRI Number |
CTRI/2025/12/099507 [Registered on: 19/12/2025] Trial Registered Prospectively |
| Last Modified On: |
19/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy of Waj in premenstrual syndrome |
|
Scientific Title of Study
|
Efficacy of Waj in premenstrual syndrome: A randomized placebo-controlled trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rifat Jahan |
| Designation |
PG SCHOLAR |
| Affiliation |
National Institute Of Unani Medicine |
| Address |
National Institute Of Unani Medicine Kottigepalya Magadi Main Road Bengaluru
National Institute Of Unani Medicine Kottigepalya Magadi Main Road Bengaluru,560091
Bangalore
KARNATAKA
560091
India |
| Phone |
8369532648 |
| Fax |
|
| Email |
rifatjahan2856@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Ismath Shameem |
| Designation |
Professor and HoD |
| Affiliation |
National Institute Of Unani Medicine |
| Address |
National Institute Of Unani Medicine Kottigepalya Magadi Main Road Bengaluru
National Institute Of Unani Medicine Kottigepalya Magadi Main Road Bengaluru,560091
Bangalore
KARNATAKA
560091
India |
| Phone |
9449977008 |
| Fax |
|
| Email |
dr.ismaths@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Ismath Shameem |
| Designation |
Professor and HoD |
| Affiliation |
National Institute Of Unani Medicine |
| Address |
National Institute Of Unani Medicine Kottigepalya Magadi Main Road Bengaluru
National Institute Of Unani Medicine Kottigepalya Magadi Main Road Bengaluru
Bangalore
KARNATAKA
560091
India |
| Phone |
9449977008 |
| Fax |
|
| Email |
dr.ismaths@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute Of Unani Medicine kottigepalya Magadi Main Road Bengaluru 560091 |
|
|
Primary Sponsor
|
| Name |
National Institute Of Unani Medicine |
| Address |
National Institute Of Unani Medicine Kottigepalya Magadi Main Road Bengaluru 560091
National Institute Of Unani Medicine Kottigepalya Magadi Main Road Bengaluru |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Rifat Jahan |
OPD 29 Ilmul Qabalat wa Amraz e Niswan |
National Institute of Unani Medicine Kottigepalya Magadi Main Road Bengaluru Karnataka 560091
National Institute Of Unani Medicine Kottigepalya Magadi Main Road Bengaluru
Bangalore
KARNATAKA |
08369532648
rifatjahan2856@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of Decision of the IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N943||Premenstrual tension syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONTROL GROUP-Placebo (Roasted wheat flour) |
Roasted wheat flour will be finely powdered and filled in the capsules and will be administered orally in a dose of 1.5 gm BD (2 capsules, one capsule is of 750mg) Route of administration and Dosage and Duration: 2 capsules will be administered orally from day 16 of the menstrual cycle till the onset of menstruation. |
| Intervention |
Waj |
After identification and authentication of the drug, Waj Will be finely powdered and filled in the capsules and will be administered orally in a dose of 1.5 gm BD (2 capsules, one capsule is of 750mg)
Route of administration and Dosage and Duration: 2 capsules will be administered orally from day 16 of the menstrual cycle till the onset of menstruation.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
35.00 Day(s) |
| Gender |
Female |
| Details |
Participants in the age group of 18-35 years with regular menstrual cycle (21-35 days).
Participants fulfilling the ACOG criteria of PMS (such as abdominal bloating, breast tenderness or swelling, headache, joint or muscle pain, swelling of the extremities, and weight gain, as well as mental symptoms, including angry outbursts, anxiety, confusion, depression, irritability, and social withdrawal) with at least 1 somatic and 1 mental symptom with moderate to severe intensity.
|
|
| ExclusionCriteria |
| Details |
Participants with
Any pelvic pathology such as uterine fibroids, ovarian cyst, endometriosis etc
Use of oral contraceptives in past 3 months and underwent hysterectomy.
K/C/O DM, HTN, thyroid dysfunction.
Depression- PHQ-9
Pregnant and Lactating women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in VAS and PMTS score |
From Day 16 of menstrual cycle till the onset of menstruation for 3 consecutive cycles |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
31/01/2026 |
| 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
|
Diagnosed cases of premenstrual syndrome fulfilling the inclusion criteria will be randomly allocated to the test and control groups. Written informed consent will be obtained from the participants. Participants and the researcher will be blinded in the study, and blinding will be done by third person. The research drug will be given to the participants in capsule form during the luteal phase of the menstrual cycle for 3 consecutive cycles. Participants will be followed every month, 10 days prior to menstruation during treatment and once after menstruation following the completion of treatment. Reduction in VAS and PMTS scores will be assessed during the trial. |