| CTRI Number |
CTRI/2026/01/102334 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
27/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Satawar on ovarian reserve in women with low AMH levels |
|
Scientific Title of Study
|
Efficacy of Satawar (Asparagus racemosus)
in enhancing serum AMH levels among
women with Diminished ovarian reserve |
| 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 Umme Aman Saba |
| Designation |
PG Scholar |
| Affiliation |
Government Nizamia Tibbi College And General Hospital |
| Address |
Department of Gynaecology and Obstetrics (Qabalath Wa Amraz e Niswan),
Government Nizamia Tibbi College and General Hospital,
Kotla Alijah, Moghalpura, Charminar, Hyderabad
Hyderabad
TELANGANA
500002
India |
| Phone |
8125970821 |
| Fax |
|
| Email |
aimanbintezakir21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Syeda Abidunnisa |
| Designation |
Professor And Guide |
| Affiliation |
Government Nizamia Tibbi College And General Hospital |
| Address |
Department of Gynaecology and Obstetrics (Qabalath Wa Amraz e Niswan),
Government Nizamia Tibbi College and General Hospital,
Kotla Alijah, Moghalpura, Charminar, Hyderabad
Hyderabad
TELANGANA
500002
India |
| Phone |
9492027082 |
| Fax |
|
| Email |
syedaabidunnisa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Syeda Abidunnisa |
| Designation |
Professor And Guide |
| Affiliation |
Government Nizamia Tibbi College And General Hospital |
| Address |
Department of Gynaecology and Obstetrics (Qabalath Wa Amraz e Niswan),
Government Nizamia Tibbi College and General Hospital,
Kotla Alijah, Moghalpura, Charminar, Hyderabad
Hyderabad
TELANGANA
500002
India |
| Phone |
9492027082 |
| Fax |
|
| Email |
syedaabidunnisa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Nizamia Tibbi College And General Hospital, Kotla Alijah, Moghalpura, Charminar, Hyderabad, Telangana, India, 500002 |
|
|
Primary Sponsor
|
| Name |
Dr Umme Aman Saba |
| Address |
Department of Gynaecology and Obstetrics (Qabalath Wa Amraz e Niswan),
Government Nizamia Tibbi College and General Hospital,
Kotla Alijah, Moghalpura, Charminar, Hyderabad, 500002 |
| 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 Umme Aman Saba |
Government Nizamia Tibbi College And General Hospital |
Department of Gynaecology and Obstetrics (Qabalath Wa Amraz e Niswan),
Government Nizamia Tibbi College and General Hospital,
Kotla Alijah, Moghalpura, Charminar, Hyderabad, 500002
Hyderabad
TELANGANA |
8125970821
aimanbintezakir21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Nizamia Tibbi College and General Hospital, Hyderabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E283||Primary ovarian failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Satawar (Asparagus racemosus) |
Formulation Type: Safoof (fine powder)
Dosage: 6 grams (3 gms in the morning, 3 gms in the evening)
Adjuvant: To be taken with lukewarm milk
Route: Oral
Duration: 90 days (3 months) |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Female patients aged between 20 and 40 years.
Serum amh levels below 1.0 ng/mL.
Regular menstrual cycle or oligo/irregular cycles.
Patients with Amenorrhea.
Infertile patients.
Willing to participate and sign the written informed consent.
Fit to take oral Unani medications for the duration of the study. |
|
| ExclusionCriteria |
| Details |
Known systemic disorders such as tuberculosis, or malignancy.
Menopause women’s.
Women with comorbidities.
Patients undergoing assisted reproductive technologies (ART) concurrently.
Pregnant or lactating women.
Hypersensitivity to the drug Administration. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Elevated Serum Anti-Müllerian Hormone (AMH) Levels |
• Baseline (Day 0)
• End of treatment – Day 90 (± 3 days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Improvement in menstrual regularity and flow pattern
• Change in Antral Follicle Count (AFC)
• Change in ovarian volume
• Absence of adverse drug reactions and assessment of safety |
• Menstrual pattern: Assessed monthly during treatment and at Day 90
• Antral Follicle Count (AFC): Assessed at baseline (Day 0) and Day 90
• Ovarian volume: Assessed at baseline (Day 0) and Day 90
• Safety parameters and adverse events: Monitored throughout the study period |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
N/A |
|
Date of First Enrollment (India)
|
09/02/2026 |
| 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 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
|
Diminished Ovarian Reserve (DOR) is a common cause of infertility in women of reproductive age and is characterized by low serum Anti-Müllerian Hormone (AMH) levels. Satawar (Asparagus racemosus) is a classical Unani drug traditionally used to improve female reproductive health and ovarian function.
This study is a prospective, open-label, single-arm interventional clinical trial conducted to evaluate the efficacy of Satawar in improving serum AMH levels among women with Diminished Ovarian Reserve. Twenty women aged 20–40 years with serum AMH levels less than 1.0 ng/mL will be enrolled after obtaining written informed consent.
Participants will receive oral Safoof-e-Satawar at a dose of 6 g/day (3 g twice daily) with lukewarm milk for a period of 90 days. The primary outcome measure is change in serum AMH levels assessed at baseline and at Day 90. Secondary outcomes include assessment of menstrual regularity, antral follicle count, ovarian volume, and safety of the intervention.
The study aims to provide clinical evidence for the role of Satawar in improving ovarian reserve in women with Diminished Ovarian Reserve. |