| CTRI Number |
CTRI/2024/12/078802 [Registered on: 31/12/2024] Trial Registered Prospectively |
| Last Modified On: |
29/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To see the effect of ayurvedic intervention and procedure in the management of menopause.
|
|
Scientific Title of Study
|
A Randomized Open Labelled Controlled Clinical Study To Evaluate The Efficacy Of Amlakyadi Ghrita And Shatavari Ghrita Nasya In The Management Of Rajonivrittijanya Lakshanas w.s.r. Post 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 Nidhi Bhawsar |
| Designation |
MS Scholar Prasuti Tantra Evam Stree Roga |
| Affiliation |
Institute For Ayurved Studies And Research Kurukshetra Haryana |
| Address |
OPD no 15 Department of Prasuti Tantra Evam Stree Roga Institute For Ayurved Studies And Research Umri Road Sector 8 Kurukshetra Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
9753337008 |
| Fax |
|
| Email |
nidhibhawsar23198@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jitesh Kumar Panda |
| Designation |
Professor and H.O.D, Department Of Prasuti Tantra Evam Stree Roga |
| Affiliation |
Institute For Ayurved Studies And Research Kurukshetra Haryana |
| Address |
Room no 112 PG Department of Prasuti Tantra Evam Stree Roga Institute For Ayurved Studies And Research Umri Road Sector 8 Kurukshetra Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
9896033056 |
| Fax |
|
| Email |
drjk67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nidhi Bhawsar |
| Designation |
MS Scholar Prasuti Tantra Evam Stree Roga |
| Affiliation |
Institute For Ayurved Studies And Research Kurukshetra Haryana |
| Address |
OPD no 15 Department of Prasuti Tantra Evam Stree Roga Institute For Ayurved Studies And Research Umri Road Sector 8 Kurukshetra Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
9753337008 |
| Fax |
|
| Email |
nidhibhawsar23198@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute
for Ayurved Studies and Research Umri road sector 08 Kurukshetra
Haryana 136118
|
|
|
Primary Sponsor
|
| Name |
Dr Nidhi Bhawsar |
| Address |
Opd no 15 PG Department of Prasuti Tantra Evam Stree Roga Institute
for Ayurved Studies and Research Umri road sector 08 Kurukshetra
Haryana 136118
|
| 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 Nidhi Bhawsar |
Institute For Ayurved Studies And Research |
Room no 112 PG Department of Prasuti Tantra Evam Stree roga
Institute For Ayurved Studies And Research sector 8 umri road kurukshetra Haryana
Kurukshetra
HARYANA |
9753337008
nidhibhawsar23198@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N951||Menopausal and female climactericstates. Ayurveda Condition: ARTAVADOSHAH/ARTAVADUSHTIH/RAJODOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Amlakyadi Ghrita, Reference: Apsmar chikitsa adhyay charak chikitsa chapter 10, Route: Nasal, Dosage Form: Ghrita, Dose: 4(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -Nasya will be given empty stomach followed by dhumpan with vacha churna and kawal by ushna ambu | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shatavari ghrita, Reference: shatpushpa shatavari kalpa adhyay kashyap samhita, Route: Nasal, Dosage Form: Ghrita, Dose: 4(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -Nasya will be given empty stomach followed by dhumpan with vacha churna and kawal by ushna ambu |
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1 Patients of age between 45 and 6o years
2 Amenorrhoea for more than or equal to 12 consecutive months
3 Kupermann menopausal index score more than or equal to 15
4 willing and able to participate for 4 weeks |
|
| ExclusionCriteria |
| Details |
1 Patients with evidence of malignancy
2 Surgical menopause
3 Patients with uncontrolled Diabetes Mellitus(Blood sugar fasting
more than 250mg/dL),uncontrolled hypertension (BP more than 160/100 mm of Hg)
4 Patients who have a past history of Atrial Fibrillation, Coronary Artery
Disease (CAD),, Acute Coronary Syndrome, Myocardial Infarction, Stroke
or Severe Arrhythmia,Renal diseases, in the last 6 months.
5 Symptomatic patients with clinical evidence of Heart failure.
6 Any other condition which the Principal Investigator thinks may jeopardize
the study.
7 Patients who are taking supplements like Vit.E, Vit D capsules. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Proportion of patients showing improvement in the level of Serum Estradiol post nasyakarma |
1ST Follow up on next day after last sitting
2nd follow up 7 days after 1st follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Reduction in symptoms of rajonivritti in the patients
2 Assessment of rajonivritti by clinical features and post menopausal syndrome by
subjective assessment criteria
3 To improve the mental & physical well being of patient
4 To improve the quality of life of patient |
1ST Follow up on next day after last sitting
2nd follow up 7 days after 1st follow up |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
01/02/2025 |
| 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 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
|
Rajonivritti is a significant event in woman’s life.It represents the end of the
reproductive era.The ancient acharyas termed it as Rajonivritti.This word is derived
from Rajah and Nivritti meaning cessation of Artava pravritti.
According to Acharya Sushrut & various other refererences 50 years is mentioned
as the age of rajonivritti when the full body is fully in grip of senility.Menopause is
the permanent cessation of menstruation for 12 consecutive months due to loss of
ovarian activity.2 Every women faces various physiological & psychological
changes during this change of life as a part of hormonal derangement sometimes
such disturbances attains the stage of disease or syndrome called as menopausal
syndrome accompanied by Vasomotor, psychological, genital. Locomotor and GIT
related symptoms.In menopause menstrual cycle stops and sex hormones level
decreases including that of estrogen.Menopause is linked with ageing which is vata
dominant stage of life,therefore symptoms of menopause experienced by some
women are similar to vriddhi lakshanas of vata dosha.There is connection between
nasa and shira. Nasa is considered as a gate way for the shira. When we
administered the drugs through nasal route, through the sukshmastrotas in nasal
route it reaches the shiragata marma and spreads throughout the mastishka and
takes out doshas from urdhvajatrugata region.Nasya karma is a natural route for
delivering, rejuvenating substance to the brain.This may be helpful to women to
enter is menopausal phase gracefully.Menopausal symptoms generally occur due to
disturbed Vata Dosha. Dhatukshay is responsible for Vata Vruddhi and vitiated Vata
Dosha affects various systems in women’s body. From the above theory we can
conclude that drugs like amlaki,madhuyashti,shatavari having properties of
2
Rasayana, Vatapitta Shaman and Kapha Vardhan can be helpful for the
management of menopausal syndrome. Therefore, it has been believed that working
in this area and making a contribution—that is, menopause from an Ayurvedic
perspective—is imperative |