| CTRI Number |
CTRI/2025/06/088820 [Registered on: 13/06/2025] Trial Registered Prospectively |
| Last Modified On: |
08/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of an Ayurvedic formulation Vyoshadi Oil in bleeding during menses occurring more than
35 days apart and in reduced bleeding during menses |
|
Scientific Title of Study
|
A randomized controlled clinical trial of Vyoshadi Tail in the management of Artavkshaya |
| 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 Anuja Ramesh Kate |
| Designation |
PG Scholar Prasutitantra avum striroga |
| Affiliation |
Matoshri Asarabai Darade Ayurveda Mahavidyalaya Babhulgaon Tal- Yeola Dist- Nashik Maharashtra |
| Address |
Department of Streeroga and Prasutitantra Matoshri Asarabai Darade Ayurveda
Mahavidyalaya Babulgaon Tal- Yeola Dist- Nashik Maharashtra Pin -423401
Nashik
MAHARASHTRA
423401
India |
| Phone |
8007599737 |
| Fax |
|
| Email |
anujakate@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sachin More |
| Designation |
Professor and Guide |
| Affiliation |
Matoshri Asarabai Darade Ayurveda Mahavidyalaya Babhulgaon Tal- Yeola Dist- Nashik Maharashtra |
| Address |
Department of Streeroga and Prasutitantra Matoshri Asarabai Darade Ayurveda
Mahavidyalaya Babulgaon Tal- Yeola Dist- Nashik Maharashtra Pin -423401
Nashik
MAHARASHTRA
423401
India |
| Phone |
9822874480 |
| Fax |
|
| Email |
sachinmore070979@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anuja Ramesh Kate |
| Designation |
PG Scholar Prasutitantra avum striroga |
| Affiliation |
Matoshri Asarabai Darade Ayurveda Mahavidyalaya Babhulgaon Tal- Yeola Dist- Nashik Maharashtra |
| Address |
Department of Streeroga and Prasutitantra Matoshri Asarabai Darade Ayurveda
Mahavidyalaya Babulgaon Tal- Yeola Dist- Nashik Maharashtra Pin -423401
Nashik
MAHARASHTRA
423401
India |
| Phone |
8007599737 |
| Fax |
|
| Email |
anujakate@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Matoshree Asarabai Darade Ayurveda Mahavidyalaya Babhulgaon Tal- Yeola Dist- Nashik
Maharashtra Pin -423401 |
|
|
Primary Sponsor
|
| Name |
Dr Anuja Ramesh Kate |
| Address |
Matoshree Asarabai Darade Ayurveda Mahavidyalaya Babhulgaon Tal- Yeola
Dist- Nashik Maharashtra Pin -423401 |
| Type of Sponsor |
Other [Self ] |
|
|
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 Anuja Ramesh Kate |
Matoshree Asarabai Darade Ayurveda Mahavidyalaya Babhulgaon Tal- Yeola |
Streeroga Prasutitantra
Opd No 8 Ground Floor
Matoshri Asarabai Darade Ayurved Hospital, Babhulgaon, Yeola
Nashik
MAHARASHTRA |
8007599737
anujakate@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Matoshri Asarabai Darade Ayurved College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E00-E89||Endocrine, nutritional and metabolic diseases. Ayurveda Condition: ARTAVAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vyoshadi Tail, Reference: Rasaratnasamuchchaya Adhyay 25 Shlok 100, Route: Oral, Dosage Form: Taila, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Shatapushpa Tail, Reference: NA, Route: Oral, Dosage Form: Taila, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Married, unmarried, nulliparous, parous, multiparous women within the age group of 18 years to menopause.
2.Patients having Artavkshaya lakshanas by Acharya Sushruta.
3.Patients having scanty menstrual flow for less than 2 days.
4.Patients with intermenstrual period more than 35 days. |
|
| ExclusionCriteria |
| Details |
Patients below 18 till menopause.
Patients having primary amenorrhea.
Major systemic disease likely to influence menstrual cycle like HTN, DM , TB , Thyroid, Renal diseases.
Known patients of malignancy, cervical erosion, polyp, adenomyosis, pelvic endometriosis , tubo-ovarian mass.
Patients undergoing treatment for any other serious illness.
Patients having gross abnormalities of the uterus.
Severe anaemia - HB less 7 gm percent
Pregnant, lactating women.
Woman having IUCD
HIV positive patients |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of Vyoshadi Tail in Artavakshaya. |
On 5th day of each menstrual cycle for 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study in detail the Nidana, Samprapti of Artavakshaya & etiopathology of oligohypomenorrhoea in detail.
2.To study the effect of Vyoshadi Tail in Artavkshaya in comparison with Shatapushpa Taila.
3.To regularize menstrual cycle & to increase amount of menstrual bleeding.
4.To assess the improvement by comparing the changes in Pictorial blood Chart before & after treatment. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 |
|
Date of First Enrollment (India)
|
25/06/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [anujakate@yahoo.com].
- For how long will this data be available start date provided 15-06-2025 and end date provided 15-06-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is Randomized controlled clinical study to evaluate the efficacy of Vyoshadi Tail orally in Artavakshaya that will be conducted in opd of Matoshree Asarabai Darade Ayurveda
Mahavidyalaya Babhulgaon.The primary outcome measures will be to assess the effect of drug
after 5days and 4 weeks and secondary outcomes will be measured after 3 menstrual cycles
during treatment and after 1 month after the treatment is completed |