| CTRI Number |
CTRI/2025/08/092540 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Natural Support for Women’s Health The Power of Zeroharm Shatavari |
|
Scientific Title of Study
|
A Clinical study to evaluate the effect of Holistic Shatavari as complete women Healthcare |
| 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 kaushalya khakhlary |
| Designation |
Associate 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 |
8638787369 |
| Fax |
|
| Email |
drkaushalya01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr kaushalya khakhlary |
| Designation |
Associate 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
ASSAM
781014
India |
| Phone |
8638787369 |
| Fax |
|
| Email |
drkaushalya01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr kaushalya khakhlary |
| Designation |
Associate 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
ASSAM
781014
India |
| Phone |
8638787369 |
| Fax |
|
| Email |
drkaushalya01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Zeroharm Sciences Private Limited 3rd Floor Unit B-23 Phase - II, Technocrat Industrial Estate Balanagar Hyderabad Telangana 500037 |
|
|
Primary Sponsor
|
| Name |
Zeroharm Sciences 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 kaushalya khakhlary |
Government Ayurvedic College and Hospital |
Department of Prasuti Tantra & Stree Roga ((Obstetrics & Gynaecology), Jalukbari Guwahti Assam Pin 781014 India Kamrup ASSAM
Kamrup
ASSAM
Kamrup
ASSAM |
86387 87369
drkaushalya01@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:N944||Primary dysmenorrhea. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Zeroharm Holistic Shatavari, 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 |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Patients with the chief complaint of Dysmenorrhoea/Menorrhagia for atleast 3 cycles
Subjects not suffering from any significant illness (medical / surgical)
Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form. |
|
| ExclusionCriteria |
| Details |
Subjects below 18 years or above 60 years of age.
Patients suffering from acute infections.
Pregnant or breast feeding women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The patient will be assessed based on their improvement in symptoms using a menstrual cycle scoring system |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Investigations: Bloodroutine, RBS, FSH,LH, Progesterone levels |
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)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/08/2025 |
| 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
|
A clinical study will be conducted to evaluate the efficacy and safety of Holistic Shatavari, an Ayurvedic formulation, in promoting women’s health and well-being. Eligible participants will receive Zeroharm Holistic Shatavari tablets daily for three months. Two follow-up visits will be scheduled at monthly intervals to assess progress. Laboratory investigations will be performed before and after the treatment to measure improvements. Key health indicators will include hormonal levels, menstrual health, energy, and mood balance. Patient-reported outcomes and symptom assessments will be recorded throughout the study. The study will also monitor for any adverse effects or safety concerns. Compliance and tolerability of the Ayurvedic formulation will be evaluated. All collected data will undergo statistical analysis to determine efficacy. This study aims to scientifically validate Holistic Shatavari as a natural support for women’s wellness. |