| CTRI Number |
CTRI/2025/07/091372 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/06/2026 |
| 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) |
05/06/2026 |
| 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
Modification(s)
|
Brief Methodology It is a single arm open label prospective interventional clinical study to evaluate the efficacy of Zeroharm Sciences Narie PCOS in the management of Poly Cystic Ovarian Syndrome (Aarthava Akshaya) Informed consent was obtained from all participants prior to enrolment. A total of 57 subjects were screened 7 were excluded for not meeting inclusion criteria, and 50 eligible female participants aged 18-45 years with confirmed PCOS/Aarthava Akshaya were enrolled. All 50 participants received Zeroharm Sciences Narie PCOS- an Ayurvedic proprietary formulation - at a dose of 550 mg tablet twice daily after food , for a duration of 3 months. Results All 50 enrolled participants completed the study.The cohort comprised female volunteers aged 18-45 years with majority of 44 % in the 25-30 years age group consistent with peak reproductive age for pcos presentation Zeroharm sciences Narie PCOS produced statistically improvement across all primary outcomes measures.PCOD resolution was the most striking finding 31 of 50 participants 62 % showed complete resolution of polycystic ovarian morphology on ultrasonography representing an absolute risk reduction of 62 %.Regularisation of menstrual cycle interval showed the most pronounced statistical effect with mean score reducing from 0.9 to 0.4.Amount of menstrual blood loss reduced significantly from mean 0.8 to 0.4.Duration of bleeding showed significant reduction from 0.6 to 0.3. Conclusion Treatment with Narie PCOS produces highly significant and clinically meaningful improvement in the management of polycystic ovarian syndrome. PCOD resolution was achieved 62 % of participants. All primary menstrual parameters - cycle interval, blood loss, and duration of bleeding showed statistically significant improvement with consistent benefit confirmed across both parametric and non - parametric analysis among hormonal parameters, TSH demonstrated significant reduction and AMH showed clinically meaningful improvement conformed by Wilcoxon test. The complete absence of adverse events across all participants demonstrates that narie PCOS is safe and exceptionally well - tolerated. Narie PCOS can be recommended as a reliable ayurvedic therapeutic option for the management of polycystic ovarian syndrome. |