| CTRI Number |
CTRI/2025/03/083115 [Registered on: 21/03/2025] Trial Registered Prospectively |
| Last Modified On: |
08/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
GudvyoShadi Vati and Shatpushpa Siddha Taila Nasya in the Management of Artavkshaya |
|
Scientific Title of Study
|
A Clinical Study to Evaluate The Combined Effect of GudvyoShadi Vati and Shatpushpa Siddha Taila Pratimarsh Nasya in the Management of Artavkshaya(Hypomenorrhea and Oligomenorrhea) |
| 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 Bhumika Sharma |
| Designation |
MS SCHOLAR |
| Affiliation |
PGIA,JODHPUR |
| Address |
PG Department of Prasuti Tantra evam Stree Roga, Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Nagaur Road Karwar Jodhpur RAJASTHAN 342037 India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9460681599 |
| Fax |
|
| Email |
sharmabhumika52@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Asha kp |
| Designation |
Associate professor |
| Affiliation |
PGIA,JODHPUR |
| Address |
PG Department of Prasuti Tantra evam Stree Roga, Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Nagaur Road Karwar Jodhpur RAJASTHAN 342037 India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9995917339 |
| Fax |
|
| Email |
dr.ashakp07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhumika Sharma |
| Designation |
MS Scholar |
| Affiliation |
PGIA,JODHPUR |
| Address |
PG Department of Panchkarma, Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Nagaur Road Karwar Jodhpur RAJASTHAN 342037 India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9460681599 |
| Fax |
|
| Email |
sharmabhumika52@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurveda Jodhpur , Rajasthan 342037 |
|
|
Primary Sponsor
|
| Name |
PGIA,JODHPUR,RAJASTHAN,INDIA |
| Address |
PG Department of Prasuti Tantra evam Stree Roga, Post Graduate Institute of Ayurved Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Nagaur Road Karwar Jodhpur RAJASTHAN 342037 India |
| Type of Sponsor |
Government medical college |
|
|
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 Bhumika Sharma |
Post Graduate Institute of Ayurved, Jodhpur, Rajasthan |
PG Department of Prasuti Tantra Evam Stri Roga Post Graduate Institute of Ayurveda Dr S R Rajasthan Ayurveda University Karwad
Jodhpur
Jodhpur
RAJASTHAN
342037
India
Jodhpur
RAJASTHAN |
9460681599
sharmabhumika52@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIA,JODHPUR,Rajasthan |
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 | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Kashyap Samhita, Procedure details: 2 Drops in each Nostril/Once a day
After cessation of menses to
14th day of menstrual cycle
Nasya for 2 consecutive
cycles. )
(1) Medicine Name: Shatpushpa Siddha Taila , Reference: Kashyap Samhita, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: od, Duration: 10 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: GudvyoShadi Vati, Reference: Ras Ratan Samucchya, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Koshna Jala), Additional Information: Duration 7 days before expected date of
menstrual cycle for 7 days. |
|
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patients willing for the trial
Patient between the age After 3 years of menarche to 40 years of age.
Oligomenorrhea (delayed menses -Interval of more than 35 days)
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.
Lactating women.
Patients with any reproductive system abnormalities like hydrosalpinx, fibroid uterus,
carcinoma of reproductive organ and sexually transmitted disease (STDs), Human
Immunodeficiency Virus (HIV), Hepatitis B Surface Antigen (HBsAg).
Systemic disorders like-uncontrolled diabetes mellitus, chronic liver disease, renal
disorder, Uncontrolled hypertension, Diagnosed case of any type of malignancy.
Patients who are contraindicated for Nasya like, Nasal polyp etc. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of
SUBJECTIVE PARAMETERS
Duration of menstrual bleeding
Interval between two cycles
Amount of menstrual flow.
Pain during menstruation.
OBJECTIVE PARAMETERS
Serum LH and serum FSH level test
Thyroid stimulating hormone test (TSH)
Ultrasonography (Pelvis) |
28 Days
(2 consecutive menstrual cycles) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Assess improvement in
SUBJECTIVE PARAMETERS
Duration of menstrual bleeding
Interval between two cycles
Amount of menstrual flow.
Pain during menstruation.
OBJECTIVE PARAMETERS
Serum LH & serum FSH level test
Thyroid stimulating hormone test (TSH)
Ultrasonography (Pelvis) |
28 Days
(2 consecutive menstrual cycles) |
|
|
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)
|
01/05/2025 |
| 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="0"
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 - NO
|
|
Brief Summary
|
Primary Objective To evaluate the effect of Gudvyoshadi Vati and Shatpushpa Siddha Taila Nasya on Artavkshaya. This is a single group experimental interventional study. A group of Diagnosed 30 patients between After 3 years of menarche to 40 yrs of Age and having Hypomenorrhoea ( scanty menses )- Score less than 10 on PBLAC and Oligomenorrhea ( delayed menses -Interval of more than 35 days) will be registered . Treatment will be given GudvyoShadi vati 1gm BD Starting 7 days before expected date of menstrual cycle for 7 days and Shatpushpa Siddha taila pratimarsh nasya 2 drops in each nostril OD starting After cessation of menses to 14th day of menstrual cycle by nasal route for 2 consecutive menstrual cycles. The clinical assessment criteria will be based on grading and scoring system of Duration of menstrual bleeding, Interval between two cycles ,Amount of menstrual flow, Pain during menstruation. |