| CTRI Number |
CTRI/2025/08/092916 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study of effect Amrutadi taila (a medicated oil) matrabasti(a panchkarma treatment in which enema given with medicated oil) in reducing the Menopause Rating Scale score in women having certain complains during perimenopausal period |
|
Scientific Title of Study
|
Randomised controlled trial of Amrutadi taila matrabasti in perimenopausal 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 Deepali Rajput |
| Designation |
PHD Scholar |
| Affiliation |
Dr D Y Patil college of Ayurveda and Research centre |
| Address |
Dept.of PrasutitantraStrirog
Dr D Y Patil College of Ayurveda and Research centre, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
02027805899 |
| Fax |
|
| Email |
drdeepalirajput@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smritika Tawre |
| Designation |
Professor and HOD |
| Affiliation |
Dr D Y Patil college of Ayurveda and research centre |
| Address |
Dept. of Prasutitantra and strirog
Dr D Y Patil college of Ayurveda and research centre, Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
02027805899 |
| Fax |
|
| Email |
smritika.taware@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Smritika Tawre |
| Designation |
Professor and HOD |
| Affiliation |
Dr D Y Patil college of Ayurveda and research centre |
| Address |
Dept. of Prasutitantra and strirog
Dr D Y Patil college of Ayurveda and research centre, Pimpri Pune
MAHARASHTRA
411018
India |
| Phone |
02027805899 |
| Fax |
|
| Email |
smritika.taware@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil college of Ayurveda and research centre, Pimpri, Pune 411018, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Dr Deepali Rajput |
| Address |
Dept of Prasutitantrastrirog, Dr D Y Patil college of Ayurveda and research centre,Pimpri,Pune 411018 |
| 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 Deepali Rajput |
Prasutitantra strirog OPD |
Dr D Y Patil Ayurvedic hospital, DR D Y Patil college of Ayurveda and research centre
Pune
MAHARASHTRA |
9423978584
drdeepalirajput@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR D Y Patil College of Ayurveda and Research Centre 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: raj, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | mAtrAbastiH, मात्राबस्तिः | (Procedure Reference: Charak samhita sutrasthan adhyaya 4 shloka 18, Procedure details: Matrabasti of 60 ml Amrutadi taila will be given daily for 8 days for 2 cycles)
(1) Medicine Name: amrutadi taila, Reference: charak sutrsthan adhyaya 4 shloka18, Route: Rectal, Dosage Form: , Dose: 60(ml), Frequency: od, Duration: 8 Days | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Ashwagandhadi Compound, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 2 Months, Reference: NA, Route: -lukewarm water, Dosage Form: Churna/ Powder, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (3) Medicine Name: Ashwagandhadi compound, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (4) Medicine Name: 2 Months, Reference: NA, Route: -lukewarm water, Dosage Form: Churna/ Powder, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Woman in late reproductive and menopause transition phase as per STRAW classification with at least three symptoms of perimenopausal syndrome as per MRS scale, woman having surgical menopause within a period of six months with at least three symptoms of perimenopausal syndrome as per MRS scale
|
|
| ExclusionCriteria |
| Details |
Patients with evidence of malignancy, established cases of mental illness, Patients suffering from major systemic illness requiring long term treatment such as DM, Rheumatoid arthritis, thyroid disorders,Patients on HRT |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Study of efficacy of Amrutadi taila matrabasti in perimenopausal syndrome |
Study of efficacy of Amrutadi taila matrabasti in perimenopausal syndrome |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Study of pathophysiology of perimenopausal syndrome as per Ayurvedic perspective,To observe side effect of amrutadi taila matrabasti if any |
|
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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="2"
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
|
Nowadays , a women spend one third of her lifespan after menopause. Due to change in lifestyle the normal physiological transition of menopause has acquired a state of disease which hampers the quality of life.The treatment available in conventional science is HRT which has major side effects such as increased risk of endometrial cancer,ovarian cancer,breast cancer and thromboembolism. In this study, Amrutadi taila (oil medicated with group of rejuvenating herbs) matrabasti will be given in patients with perimenopausal syndrome. Total seventy patients will be slelected and randomly divided in to two groups. Results will be assessed using Modified MRS Scale. |