| CTRI Number |
CTRI/2025/02/081301 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Jatamansi,Shatavari & Ashwagandha in the Management of Rajonivrutti Lakshanas w.s.r to Menopausal Syndrome |
|
Scientific Title of Study
|
A Clinical study to Evaluate the Efficacy of Jatamansi Shatavari and Ashwagandha in the management of Rajonivrutti Lakshanas w.s.r to Menopausal Syndrome |
| 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 Adhyaru Hiralben Prakashbhai |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurvedic College and Hospital Kadamkuan Patna Bihar |
| Address |
Department of Prasutitantra evum Striroga,Government Ayurvedic College and Hospital Kadamkuan Patna Bihar 800003
Patna
BIHAR
800003
India |
| Phone |
9714834612 |
| Fax |
|
| Email |
adhyaruhiral74@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prabha Kumari |
| Designation |
Associate professor and head of department |
| Affiliation |
Government Ayurvedic College and hospital Kadamkuan Patna Bihar |
| Address |
Department of Prasuti tantra Evum stri roga
Government Ayurvedic College and hospital Kadamkuan Patna Bihar 800003
Patna
BIHAR
800003
India |
| Phone |
7004860634 |
| Fax |
|
| Email |
dr.prabhapandey@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Adhyaru Hiralben Prakashbhai |
| Designation |
PG Scholar, Prasutitantra evum Streeroga department, GACH, Patna |
| Affiliation |
Government Ayurvedic College and Hospital Kadamkuan Patna |
| Address |
Department of Prasuti tantra Evum stri roga
Government Ayurvedic College and hospital Kadamkuan Patna Bihar 800003
Patna
BIHAR
800003
India |
| Phone |
9714834612 |
| Fax |
|
| Email |
adhyaruhiral74@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College and Hospital Kadamkuan Patna Bihar India 800003 |
|
|
Primary Sponsor
|
| Name |
Government Ayurvedic College and Hospital Patna |
| Address |
Government Ayurvedic College and Hospital Kadamkuan Patna Bihar India 800003 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Prabha Kumari |
GACH,PATNA |
OPD-01 Department of Prasutitantra evum Striroga, Government Ayurvedic College and Hospital Kadamkuan Patna Bihar
Patna
BIHAR |
7004860634
dr.prabhapandey@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMITTEE,PATNA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N959||Unspecified menopausal and perimenopausal disorder. Ayurveda Condition: RAJONASAH (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Jatamansi, Shatavari and Ashvagandha Choorna, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Lukewarm milk ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
-Patients willing for trial.
-The age group of patients will between 45 to 60 yr.
-Patients who having Cardinal symptom i.e.cessation of menstruation cycle for 12 consecutive
month and having other symptoms as per menopausal rating scale (MRS) |
|
| ExclusionCriteria |
| Details |
-surgical menopause
-Patients with poorly controlled Diabetes Mellitus.
-Symptomatic patients with clinical evidence of Heart failure.
-Alcoholic and drug Abuser.
-Patient on prolonged (greater than 6 weeks)
Medication with Corticosteroid, Anti Depressants, anticholinergic drugs
-Taking Hormone Replacement Therapy (HRT).
-Women who had undergone hysterectomy
-Taking contraceptive |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Menopause Rating Scale (MRS) |
2 months (BT and AT) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in sign & symptoms of menopause |
2 months (BT & AT) |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
06/03/2025 |
| 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
|
A study entitled “A clinical study to evaluate the efficacy of Jatamansi, Shatavari & Ashwagandha in the management of Rajonivruti Lakshanas-menopausal syndrome.-single arm study”. Rajonivruti deals with Jarapakvavastha. Aim of the study are to study the detailed eitiopathogenesis of the menopausal syndrome according to Ayurveda and Modern science and To Evaluate of Efficacy of Jatamansi, Shatavari & Ashwagandha in the management of Menopausal syndrome. 40 patients of menopausal syndrome, aged between 45 to 60 years will be selected for study. Jatamansi, Shatavari & Ashwagandha Choorna will be given 3 gm to the patient BD (morning and night) with lukewarm milk. Assessment will be done by Menopausal Rating Scale BT and AT.
|