| CTRI Number |
CTRI/2026/03/106679 [Registered on: 23/03/2026] Trial Registered Prospectively |
| Last Modified On: |
19/03/2026 |
| 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
|
A study on the effect of Indian Costus root versus placebo on absence of menses related to Thyroid problem |
|
Scientific Title of Study
|
EFFICACY OF QUST SHIREEN (Saussurea lappa) ON SECONDARY AMENORRHEA DUE TO HYPOTHYROIDISM (EHTEBAS E TAMS BA SABAB QILLAT-E-DARQIYYAT)”RANDOMISED PLACEBO CONTROLLED STUDY.
|
| 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 Farheen Taqi |
| Designation |
PG scholar |
| Affiliation |
Government Nizamia Tibbi college and General hospital |
| Address |
OPD room no 8 PG Department of Obstetrics and Gynecology Government Nizamia Tibbi College and General Hospital Charminar
NIL
Hyderabad
TELANGANA
500002
India |
| Phone |
7207880594 |
| Fax |
|
| Email |
farheentaqi97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shahzadi Sultana |
| Designation |
HOD and Professor |
| Affiliation |
Government Nizamia Tibbi college and General Hospital |
| Address |
OPD room no 8 PG Department of Obstetrics and Gynecology Government Nizamia Tibbi College and General Hospital Charminar
NIL
Hyderabad
TELANGANA
500002
India |
| Phone |
9908624090 |
| Fax |
|
| Email |
drssntc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Farheen Taqi |
| Designation |
PG Scholar |
| Affiliation |
Government Nizamia Tibbi college and General hospital |
| Address |
OPD room no 8 PG Department of Obstetrics and Gynecology Government Nizamia Tibbi College and General Hospital Charminar
Bbbh
Hyderabad
TELANGANA
500002
India |
| Phone |
7207880594 |
| Fax |
|
| Email |
farheentaqi97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Nizamia Tibbi college and General Hospital Charminar Hyderabad Telangana 500002 India |
|
|
Primary Sponsor
|
| Name |
Government Nizamia Tibbi college |
| Address |
Government Nizamia Tibbi college and General hospital Charminar Hyderabad |
| Type of Sponsor |
Government medical college |
|
|
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 Farheen Taqi |
Government Nizamia Tibbi college |
OPOPD room no 8 PG Department of Obstetrics and Gynecology Government Nizamia Tibbi College and General Hospital Charminar
Hyderabad
TELANGANA |
7207880594
farheentaqi97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Nizamia Tibbi college Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N911||Secondary amenorrhea, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo (corn starch) |
Patients in Group B will given 3gms of placebo per day in the form of capsule in two divided doses for 15 days for 3 consecutive cycles ( accordingly) |
| Intervention |
Qust shireen |
Patients of Group A will be given Indian Costus powder 3gms per day in the form of capsule in two divided doses (1.5 g BD) for 15 days for three consecutive cycles accordingly. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Hypothyroidism diagnosed on basis of Zulewski scoring, USG whole abdomen and pelvis and Thyroid profile. Women within age of 15-40 years. Both married and unmarried. Both nulliparous and multiparous. |
|
| ExclusionCriteria |
| Details |
1.Patient with Severe Anaemia less than 8 gms
2.Use of hormonal therapy such as Oral contraceptives in the previous 3 months.
3.Thyroid dysfunction due to other causes such as Grave’s disease.
4.Patient with active or history of TB or Asthma.
5.Pregnancy
6.Lactation
|
|
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Method of Generating Random Sequence
|
Stratified randomization |
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Method of Concealment
|
Alternation |
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Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To restore the menstrual cycle and to control the symptoms of hypothyroidism |
0th day to 90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Zulewski scoring, Arbitary scaling for menstrual cycle pattern |
Assessments will be done at baseline (Day 0),Day 30, Day 60 and Day 90. |
|
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/04/2026 |
| 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
|
Title of the study: Efficacy of qust shireen (saussurea lappa) on secondary amenorrhea due to hypothyroidism- randomised placebo controlled study.
Aims of the study: 1.To prove the efficacy of Qust Shireen in the management of Secondary amenorrhea due to Hypothyroidism. 2.The primary goal of the Study is to restore the menstrual cycle.
Inclusion criteria: Hypothyroidism diagnosed on basis of Zulewski scoring, USG whole abdomen and pelvis and Thyroid profile. Women within age of 15-40 years. Both married and unmarried. Both nulliparous and multiparous.
Exclusion criteria:
1.Patient with Severe Anaemia less than 8 gms 2.Use of hormonal therapy such as Oral contraceptives in the previous 3 months. 3.Thyroid dysfunction due to other causes such as Grave’s disease. 4.Patient with active or history of TB or Asthma. 5.Pregnancy 6.Lactation
Intervention: Group A: Qust shireen (Saussurea lappa) Group B: Corn Starch
Duration of treatment: 3months
Patients of Group A will be given Indian Costus powder 3gms per day in the form of capsule in two divided doses (1.5 g BD) for 15 days for three consecutive cycles accordingly. Patients in Group B will given 3gms of placebo per day in the form of capsule in two divided doses for 15 days for 3 consecutive cycles (accordingly)
Outcomes: 1. Primary outcome: To restore the menstrual cycle and to control the symptoms of hypothyroidism. 2. Secondary outcome: Zulewski scoring, Arbitary scaling for menstrual cycle pattern.
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