| CTRI Number |
CTRI/2025/07/091372 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on Narie PCOS to evaluate it’s efficacy in the management of Poly Cystic Ovarian Syndrome |
|
Scientific Title of Study
|
A Clinical study to evaluate the efficacy of Narie PCOS in the management of Poly Cystic Ovarian Syndrome (Aarthava Akshaya) |
| 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 Dipak Kumar Goswami |
| Designation |
Assistant Professor |
| Affiliation |
Government Ayurvedic College, Jalukbari, Guwahati -14 , Assam |
| Address |
Department of Prasuti Tantra & Stree Roga ((Obstetrics & Gynaecology)
Government Ayurvedic College, Jalukbari, Guwahati -14 , Assam
Kamrup
ASSAM
781014
India |
| Phone |
9435400876 |
| Fax |
|
| Email |
dr.dkgoswami@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dipak Kumar Goswami |
| Designation |
Assistant Professor |
| Affiliation |
Government Ayurvedic College and Hospital |
| Address |
Department of Prasuti Tantra & Stree Roga ((Obstetrics & Gynaecology)
Government Ayurvedic College, Jalukbari, Guwahati -14 , Assam
Kamrup
ASSAM
781014
India |
| Phone |
9435400876 |
| Fax |
|
| Email |
dr.dkgoswami@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dipak Kumar Goswami |
| Designation |
Assistant Professor |
| Affiliation |
Government Ayurvedic College and Hospital |
| Address |
Department of Prasuti Tantra & Stree Roga ((Obstetrics & Gynaecology)
Government Ayurvedic College, Jalukbari, Guwahati -14 , Assam
Kamrup
ASSAM
781014
India |
| Phone |
9435400876 |
| Fax |
|
| Email |
dr.dkgoswami@gmail.com |
|
|
Source of Monetary or Material Support
|
| Zeroharm Sciences Private Limited |
|
|
Primary Sponsor
|
| Name |
Zeroharm Science Private Limited |
| Address |
Unit No. B 23, Phase 2 Technocrat, Cooperative Industrial Estate, Balanagar, Hyderabad, Telangana, Pin 500037, India |
| Type of Sponsor |
Other [Neutracutical company ] |
|
|
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 Dipak Kumar Goswami |
Government Ayurvedic College and Hospital |
Department of Prasuti Tantra & Stree Roga ((Obstetrics & Gynaecology), Jalukbari Guwahti Assam Pin 781014 India
Kamrup
ASSAM
Kamrup
ASSAM |
9435400876
dr.dkgoswami@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee Govt Ayurvedic College Jalukbari Guwahati Assam |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E282||Polycystic ovarian syndrome. Ayurveda Condition: ARTAVAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Narie PCOS, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 550(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Patient diagnosed with PCOS
2. Patient with chief complain of Irregular menses / scanty menses
3. Patients suffer infertility due to PCOS.
4.Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form. |
|
| ExclusionCriteria |
| Details |
Pregnant or Lactating women
Congenital anomalies in female genital tract or Congenital adrenal hyperplasia
Malignant diseased patients and cytotoxic patients. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment Criteria (Based on Grade & Score) 1. Duration of bleeding
2. Irregular menstruation
3. Amount of bleeding and quantity of menstrual blood
4. Pain during menstrual period
|
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Haematological- CBC, ESR, Blood group, Urine (R/M), LH,FSH
Follicular study- A serial vaginal or abdominal sono graphy was done from 10th day of menstrual cycle,till after ovulation. |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/08/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The eligible patients of PCOS will be treated with Narie PCOS an ayurvedic medicine for a duration of three months. Two follow ups will be carried out at the interval of 1 month. Before and After the treatment, laboratory investigations will be carried out to find out the improvements of the patients. |