| CTRI Number |
CTRI/2026/02/102669 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
30/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study On The Effect Of hot oil poured over forehead And Oil Enema In after Menopause Vata Disorders |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Study On Efficacy Of Shirodhara And Matra Basti In Vatavyadhi w.s.r. To 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 Pratibha Rawat |
| Designation |
MD Scholar |
| Affiliation |
National Institute Of Ayurveda,Jaipur |
| Address |
ROOM NO 116,Panchakarma Department,National Institute Of Ayurveda,Jorawar Singh Gate,Amer Road,Jaipur302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9649371019 |
| Fax |
|
| Email |
pratibharawat273@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarvesh Kumar Singh |
| Designation |
Associate Professor |
| Affiliation |
National Institute Of Ayurveda,Jaipur |
| Address |
ROOM NO 116,Panchakarma Department,National Institute Of Ayurveda,Jorawar Singh Gate,Amer Road,Jaipur302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
8739860237 |
| Fax |
|
| Email |
sarveshksingh21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarvesh Kumar Singh |
| Designation |
Associate Professor |
| Affiliation |
National Institute Of Ayurveda,Jaipur |
| Address |
ROOM NO 116,Panchakarma Department,National Institute Of Ayurveda,Jorawar Singh Gate,Amer Road,Jaipur302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
8739860237 |
| Fax |
|
| Email |
sarveshksingh21@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institutes Of Ayurveda,Deemed to be University,Amer road jorawar singh gate . Jaipur Rajasthan 302001 |
|
|
Primary Sponsor
|
| Name |
National Institute Of Ayurveda |
| Address |
Madhav Vilas Palace,Jorawar Singh Gate,Amer Road,Jaipur,302002 |
| 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 Sarvesh Kumar Singh |
National Institute Of Ayurveda |
O.P.D.
No.-2,and IPD Panchkarma
Department,Madhav
Vilas Palace,Jorawar
Singh Gate,Amer Road,
Jaipur,302002,Rajasthan,
India.
Jaipur
RAJASTHAN |
8739860237
sarveshksingh21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National Institute Of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N958||Other specified menopausal and perimenopausal disorders. Ayurveda Condition: VATAVYADHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | aBya~ggaH, अभ्यंग | (Procedure Reference: charak siddhi 1/29, Procedure details: whole Body Massage is Done with oil followed by sarvanga swedan)
(1) Medicine Name: Dashmoola taila, Reference: bhaishajiya ratnawali shirorogaadhikara 65/69, Route: Topical, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 14 Days | | 2 | Intervention Arm | Procedure | - | mAtrAbastiH, मात्राबस्तिः | (Procedure Reference: Charak chikitsa 28/217, Procedure details: Per rectal administration of oil once a day for 7 days followed by asministration of hot oil dhara over forehead once a day for 7 days.)
(1) Medicine Name: Prasarini taila, Reference: bhava prakash chikitsa 24/32, Route: Rectal, Dosage Form: Taila, Dose: 72(ml), Frequency: od, Duration: 7 Days(2) Medicine Name: Prasarini taila, Reference: bhava prakash chikitsa 24/32, Route: Topical, Dosage Form: Taila, Dose: 1000(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1.Female With Psychosocial And Vasomotor Symptoms, Depression, Anxiety And Menopausal Related Symptoms.
2. Females In Post-Menopausal Phase.
3.Patient Willing And Able To Participate In This Study For Entire Trial Period With Informed Consent.
4.Patient Fit For Matra Basti Karma.
5.Patients With A Washout Period Of 15 Days, Who Have Been Taking Medication Or Panchakarma Therapy For Same Condition. |
|
| ExclusionCriteria |
| Details |
1. Patient, Suffering From Any Acute Or Chronic Debilitating Disease (Conditions Involving Cardiac, Vascular, Hematological, Respiratory, Hepatic, Gastrointestinal, Renal Functions, Endocrinal, Central Nervous System. Or Active Cancer) And Having Other Serious Pathology.
2. Patients With Long Term Steroid Treatment.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary Outcome: Changes In Beck’s Depression Inventory Scale Of Post-Menopausal Women. |
At baseline,14th , 28th day in each arm |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in Beck’s Anxiety Inventory & MenQoL (Menopause- specific quality of life) scale & biochemical changes in investigations ( CBC,ESR, SGOT,SGPT ) of post-menopausal women. |
At baseline ,14th ,28th day in each arm |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/08/2026 |
| 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="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 - NO
|
|
Brief Summary
|
INTRODUCTION- The condition known as menopause is when ovarian function gradually deteriorates to the point that menstruation permanently stops. Early symptoms during the menopausal transition and late symptoms following menopause can be caused by an estrogen shortage. The menopause is a typical stage of life. Women must adjust to changing biological, social, and psychological norms at this time. Among the most prevalent menopausal symptoms are vasomotor symptoms. Data indicates that post-menopausal women are more likely to acquire depressive disorders, even in the absence of a prior history, although menopause or post-menopause itself is not linked to any particular psychiatric diseases. Neuroticism, worry, stress, impaired cognitive function, and mood and sleep disorders are all associated with vasomotor symptoms. Vasomotor symptoms during the menopausal transition phase are also significantly mediated by personality traits, social variables, and other factors. Menopausal vasomotor symptoms are linked to substantial societal expenses. There are numerous traditional hormone therapy, and complementary and alternative therapy including over the counter treatments and dietary supplements for managing post menopause related vasomotor symptoms. Additional costs include follow-up physician visits, laboratory testing, management of adverse events, and loss of productivity at work. Social support and planning may help women to deal with menopausal symptoms and may reduce overall social costs during this transitional phase. Need of study- Psychosocial and vasomotor symptoms are common during post menopause due to hormonal fluctuations and other physiological changes. Overall, the prevalence of psychosocial and vasomotor symptoms during post menopause underscores the importance of addressing these issues to improve the overall well-being and quality of life of women transitioning through this stage of life. Studying psychosocial and vasomotor symptoms is vital to understand their complex mechanisms, develop effective treatments, improve care delivery, and ultimately reduce the burden of mental health issues on individuals and society.
RESEARCH QUESTIONS-Is Matra Basti and Shirodhara is effective in vatavyadhi with special reference to psychosocial and vasomotor symptoms in post-menopausal women. HYPOTHESIS: Null Hypothesis (H0) - There is no effect of Matra Basti and Shirodhara in vatavyadhi with special reference to psychosocial and vasomotor symptoms in post-menopausal women. Alternative Hypothesis (H1)- There is significant effect of Matra Basti and Shirodhara in vatavyadhi with special reference to psychosocial and vasomotor symptoms in post-menopausal women. AIM: The aim of the study is to assess efficacy of Shirodhara and Matra Basti in Vatavyadhi with special reference in post-menopausal women. OBJECTIVES: Primary objective -To evaluate the changes in Beck’s Depression Inventory Scale in post-menopausal women. Secondary objective - To evaluate the changes in Beck’s Anxiety Inventory and MenQol (Menopause- specific quality of life) scale in post-menopausal women. |