| CTRI Number |
CTRI/2025/02/081379 [Registered on: 27/02/2025] Trial Registered Prospectively |
| Last Modified On: |
13/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Clinical Study of Shalmali Ghee and Shatavari Ghee in the Treatment of Abnormal Menstrual Bleeding (Asrigdar) |
|
Scientific Title of Study
|
A Comparative Clinical Evaluation Of Shalmali Ghrit And Shatvari Ghrit In The Management Of Asrigdar |
| 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 Pooja Sahu |
| Designation |
M.S. Scholar |
| Affiliation |
Government Ayurvedic PG College And Hospital Chaukaghat,Varanasi |
| Address |
Department of Prasuti Tantra and Stri Roga Government Ayurvedic PG College And Hospital,Chaukaghat,Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
7974360344 |
| Fax |
|
| Email |
psahu111993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepika Gupta |
| Designation |
Assistant Professor |
| Affiliation |
Government Ayurvedic PG College And Hospital Chaukaghat, Varanasi |
| Address |
Department of Prasuti Tantra and Stri Roga Government Ayurvedic PG College And Hospital,Chaukaghat,Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9839076961 |
| Fax |
|
| Email |
deepikagupta0717@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anjana Saxena |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurvedic PG College And Hospital,Chaukaghat,Varanasi |
| Address |
Department of Prasuti Tantra and Stri Roga Government Ayurvedic PG College And Hospital,Chaukaghat,Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9839041045 |
| Fax |
|
| Email |
dranjana.saxena@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic P.G. College And Hospital Chaukaghat Varanasi, Uttar Pradesh, 221002, India |
|
|
Primary Sponsor
|
| Name |
Government Ayurvedic P.G. College And Hospital Chaukaghat Varanasi |
| Address |
Department of Prasuti Tantra and Stri Roga Government Ayurvedic
College and Hospital, Varanasi
Varanasi
UTTAR PRADESH
221002 |
| 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 Pooja Sahu |
Government Ayurvedic P G College And Hospital Chaukaghat Varanasi |
OPD No 36 and OPD No 1 Department of Prasuti Tantra and Stri Roga Government Ayurvedic PG College And Hospital,Chaukaghat,Varanasi.Uttar Pradesh.
Varanasi
UTTAR PRADESH |
7974360344
psahu111993@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government PG Ayurveda College and Hospital, Varanasi, U.P Mahayogi Guru Gorakhnath Ayush University, Gorakhapur, U.P. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N921||Excessive and frequent menstruation with irregular cycle. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shatavari Ghrita, Reference: Kashyapa Kalpasthana Shatpushpashatavari Adhyaya, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 42 Days, anupAna/sahapAna: Yes(details: Koshna Jala), Additional Information: | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shalmali Ghrita, Reference: Yogaratnakar Pradara Roga Chikitsa, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 42 Days, anupAna/sahapAna: Yes(details: Koshna Jala), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Patients who are willing to participate in the trial, including both married and unmarried individuals, will be included. The primary eligibility criterion is the presence of Asrigdara as a cardinal symptom. Additionally, the study will consider patients within the age range of 18 to 45 years. |
|
| ExclusionCriteria |
| Details |
Patients who are not willing to participate in the trial will be excluded. Additionally, individuals with hemoglobin levels below 8 gm%, pregnant patients, and lactating women will not be considered. Those using intrauterine contraceptive devices (IUCDs) or oral contraceptive pills (OCPs) are also ineligible. Exclusion criteria further include bleeding from sites other than the uterus, bleeding due to abortion, postmenopausal bleeding, and systemic illnesses such as severe hypertension, liver dysfunction, thyroid disorders, and sexually transmitted diseases (STDs). Patients with coagulation disorders or those diagnosed with uterine and pelvic pathologies, including fibroids, adenomyosis, pelvic inflammatory disease (PID), endometrial polyps, and cervical cancer, will also be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Normalization of Menstrual Cycle
2.Reduction in Spotting or Pre-menstrual Bleeding |
3 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in associate symptoms like angamarda kathishool aruchi daurbalya bhram tamoPravesh tandra etc |
3 Months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/03/2025 |
| Date of Study Completion (India) |
03/04/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Interventional study Patient suffering from Asrigdar will be selected from OPD and IPD of Department of Prasuti Tantra evum Stri Roga , Government PG Ayurvedic College and Hospital Chaukaghat Varanasi. Total 60 patients will be selected for the study of the drug. Treatment will continue for 3 consecutive months (90 days). Treatment protocol - patients are divided into two groups of 30-30 patients.
GROUP-A (TREATMENT GROUP): It consists of 30 patients who will be given the selected drug SHALMALI GHRITA orally. Dose: 6 gm BD in PRAGBHAKTA kala, for 3 consecutive months. GROUP-B (CONTROL GROUP): It also consists of a group of 30 patients who will be given SHATAVARI GHRITA orally. Dose: 6 gm BD in PRAGBHAKTA kala, for 3 consecutive months. Follow Up: On 15th,30th, 45th, 60th, 75th, 90th days |