| CTRI Number |
CTRI/2023/07/055655 [Registered on: 25/07/2023] Trial Registered Prospectively |
| Last Modified On: |
22/07/2023 |
| 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
|
SHATAPUSHPA GHRUTPAN WITH YONIPICHOO IN THE MANAGEMENT OF RAJONIVRITTI |
|
Scientific Title of Study
|
Randomized Controlled Clinical Trial To Evaluate The Efficacy Of Shatapushpa Ghrutapan With Yonipichoo In The Management Of Rajonivritti 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 |
Shamika sameer joshi |
| Designation |
Associate Professor |
| Affiliation |
Chatrapati Shahu Maharaj Shikhan Sanstha Ayurvedic College Kanchanwadi Chh.Sambhaji Nagar |
| Address |
Chatrapati Shahu Maharaj Shikshan Sanstha Ayurved college and hospital ,Stree Rog Prasuti tantra department no 1 Kanchanwadi (Aurangabad), chatrapati sambhaji Nagar
Chatrapati Shahu Maharaj Shikshan Sanstha Ayurved college and hospital ,Stree Rog Prasuti tantra department no 1 Kanchanwadi (Aurangabad), chatrapati sambhaji Nagar
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9604337319 |
| Fax |
0240-2646222 |
| Email |
paithankarmedha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayashri S. Deshmukh |
| Designation |
Professor |
| Affiliation |
Chatrapati Shahu Maharaj Shikhan Sanstha Ayurvedic College Kanchanwadi Chh.Sambhaji Nagar |
| Address |
Chatrapati Shahu Maharaj Shikshan Sanstha Ayurved college and hospital ,Stree Rog Prasuti tantra dept no 1 Kanchanwadi (Aurangabad), chatrapati sambhaji Nagar
Chatrapati Shahu Maharaj Shikshan Sanstha Ayurved college and hospital ,Stree Rog Prasuti tantra dept no 1 Kanchanwadi (Aurangabad), chatrapati sambhaji Nagar
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9325580777 |
| Fax |
0240-2646222 |
| Email |
dr.jayashrisdeshmukh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shamika sameer joshi |
| Designation |
Associate Professor |
| Affiliation |
Chatrapati Shahu Maharaj Shikshan Sanstha Ayurvedic College Kanchanwadi Chh.Sambhaji Nagar |
| Address |
Chatrapati Shahu Maharaj Shikshan Sanstha Ayurved college and hospital ,Stree Rog Prasuti tantra dept no 1 Kanchanwadi (Aurangabad), chatrapati sambhaji Nagar
Chatrapati Shahu Maharaj Shikshan Sanstha Ayurved college and hospital ,Stree Rog Prasuti tantra dept no 1 Kanchanwadi (Aurangabad), chatrapati sambhaji Nagar
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9604337319 |
| Fax |
0240-2646222 |
| Email |
paithankarmedha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chatrapati Shahu Maharaj Shikshan Sanstha Ayurved college and hospital , Kanchanwadi (Aurangabad), chatrapati sambhaji Nagar |
|
|
Primary Sponsor
|
| Name |
Shamika Sameer Joshi |
| Address |
CSMSS AYURVEDIC COLLEGE KANCHANWADI AURANGABAD |
| 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 Shamika Sameer Joshi |
Chatrapati Shahu Maharaj shikshan Sanstha Ayurvedic COLLEGE |
Stree rog & Prasuti Tantra Department no.-01, Kanchanwadi, Paithan Road Aurangabad.
Aurangabad
MAHARASHTRA |
9604337319
0240-2646222
paithankarmedha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CSMSS Ayurved Mahavidyalaya Kanchanwadi /IEC-2021/40 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N951||Menopausal and female climactericstates, (2) ICD-10 Condition:N951||Menopausal and female climactericstates. Ayurveda Condition: RAJONASAH (KEVALAVATA), (3) ICD-10 Condition: N951||Menopausal and female climactericstates, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shatapushpa , Reference: Kashyap Samhita, Route: Oral, Dosage Form: Ghrita, Dose: 40(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -koshna jal), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shatavari, Reference: Kashyap, Route: Oral, Dosage Form: Ghrita, Dose: 40(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Koshna jal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1.Cessation of menstruation for consecutive 12 month
2. Age between of PostMenopausal symptoms.i.e. Hot Flushes (daha)
Excessive swetting(swedadhikya)
Sleep Disturbance(Asmyaknidra)
Backache(Katishool)
Drynes of vagina (Yonishushkata) |
|
| ExclusionCriteria |
| Details |
1.Age below 45 years and more than 55 years.
2.Diagnosed patient of diabetes and hypertension
3.Diagnosed patient of psychological disorder or any systemic disease.
4.Perimenopausal women or uterine prolapse any malignancy.
5.Patient who have undergo hysterectomy |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of shatapushpa Ghrutpan with Yonipichu in the management of Rajonivritti |
1year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the effect of Shatavari Ghrutapan with yonipichu in the management of Rajonivritti
2.To compare effect of Shatapushpa Ghrutapan with yoni pichu & Shatavari Ghrutapan with yoni pichu in the management of Rajonivritti
3.To study Menopasue according to modern. |
To study the effect of Shatavari Ghrutapan with yonipichu in the management of Rajonivritti-6 months
2.To compare effect of Shatapushpa Ghrutapan with yoni pichu & Shatavari Ghrutapan with yoni pichu in the management of Rajonivritti-8 months
3.To study Menopasue according to modern. 9 months |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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 3 |
|
Date of First Enrollment (India)
|
28/08/2023 |
| 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="0"
Months="6"
Days="10" |
|
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
|
menopause is defined as the permenant cessation of the menstrual cycle .The prevalnce of menopausal symptoms was found to be 47 % Acording to literature 60% of ladies suffer from mild symptoms and 20% suffer from severe symptoms . hence to improve of quality of life in post menopausal women the study is being conducted. |