| CTRI Number |
CTRI/2026/03/105832 [Registered on: 10/03/2026] Trial Registered Prospectively |
| Last Modified On: |
10/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to Evaluate the Effect of Jyotishmatyadi Yoga Vati in Women having Reduced Menstrual Flow |
|
Scientific Title of Study
|
An Exploratory Clinical Study To Evalute Effect Of Jyotishmatyadi Yoga Vati In The Management Of Artava Kshaya (Hypomenorrhea) |
| 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 Bhuvneshwari Sharma |
| Designation |
P.G. Scholar |
| Affiliation |
Post Graduate Institute of Ayurved Dr S R Rajasthan Ayurved University Jodhpur |
| Address |
PG dept of Stree roga Prasuti Tantra Post Graduate Institute of Ayurveda Dr S R Rajasthan Ayurved University Jodhpur Rajasthan 342037 India
Jodhpur RAJASTHAN 342037 India |
| Phone |
8619487967 |
| Fax |
|
| Email |
yeahitsbhuvi@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr A Neelima |
| Designation |
Professor & HOD |
| Affiliation |
Post Graduate Institute of Ayurved Dr S R Rajasthan Ayurved University Jodhpur |
| Address |
Department of Stree Roga-Prasuti Tantra Post Graduate Institute of Ayurveda Opd No 5 Dr S R Rajasthan Ayurved University Jodhpur Rajasthan 342037 India
Jodhpur RAJASTHAN 342037 India |
| Phone |
9610350131 |
| Fax |
|
| Email |
aspneelima@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Bhuvneshwari Sharma |
| Designation |
P.G. Scholar |
| Affiliation |
Post Graduate Institute of Ayurved Dr S R Rajasthan Ayurved University Jodhpur |
| Address |
Department of Stree Roga-Prasuti Tantra Post Graduate Institute of Ayurveda Opd No 5 Dr S R Rajasthan Ayurved University Jodhpur Rajasthan 342037 India
Jodhpur RAJASTHAN 342037 India |
| Phone |
8619487967 |
| Fax |
|
| Email |
yeahitsbhuvi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurved Jodhpur Rajasthan India 342037 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurved Jodhpur Rajasthan India 342037 |
| Address |
PG Dept of Stree Roga Prasuti Tantra Post Graduate Institute of Ayurved Dr S R Rajasthan Ayurved University Jodhpur Rajasthan India 342037 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Bhuvneshwari Sharma |
PG Dept of Stree Roga Prasuti Tantra Post Graduate Institute of Ayurved Dr S R Rajasthan Ayurved University Jodhpur Rajasthan India 342037 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bhuvneshwari Sharma |
Post Graduate Institute of Ayurveda Jodhpur Rajasthan |
Post Graduate Institute of Ayurveda Dr S R Rajasthan Ayurved University Jodhpur Rajasthan 342037 India Jodhpur RAJASTHAN |
8619487967
yeahitsbhuvi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee Post Graduate Institute of Ayurved |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N915||Oligomenorrhea, unspecified. Ayurveda Condition: ARTAVAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: JYOTISHMATYADI YOGA VATI, Reference: Bhavprakash madhya khanda, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -Milk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Inclusion criteria -
1 Patients willing for the trial
2 Patient who has completed 3 years after menarche to 40 years of age.
3 Hypomenorrhea (scanty menses)- Score less than 10 on PBLAC |
|
| ExclusionCriteria |
| Details |
Patient less than 3 years of menarche and more than 40 years of age.
1 Lactating women.
2 Patients with any reproductive system abnormalities like hydrosalpinx, fibroiduterus, carcinoma of reproductive organ and sexually transmitteddisease (STDs), Human Immunodeficiency Virus (HIV), Hepatitis B Surface Antigen (HBsAg).
3 Systemic disorders like-uncontrolled diabetes mellitus, chronic liver disease, renal disorder, Uncontrolled hypertension, Diagnosed case of any type of malignancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce Artava Kshaya. |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcome: Relief in abdominal pain, duration and interval |
2 months |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/05/2026 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Summary:This is an open label single arm exploratory interventional study enrolling thirty patients diagnosed with Artava Kshaya or Hypomenorrhea. The study design is interventional non randomized open label single arm with no comparator or placebo. Participants will receive Jyotishmatyadi Yoga Vati at a dose of five hundred milligrams per tablet two tablets twice daily with milk. The primary objective is to assess improvement in menstrual flow and cycle regularity. The secondary objective is to evaluate symptom relief and safety. The outcomes include menstrual blood volume cycle pattern symptom changes and safety profile. |