| CTRI Number |
CTRI/2024/12/078249 [Registered on: 17/12/2024] Trial Registered Prospectively |
| Last Modified On: |
17/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Tilmooladi Churna with Lekhaniya Matra Basti on Polycystic Ovarian Syndrome. |
|
Scientific Title of Study
|
A CLINICAL STUDY TO EVALUATE THE EFFICACY OF TILMOOLADI CHURNA AND LEKHANIYA MATRA BASTI ON VATA-KAPHAJA ARTAVADUSHTI W.S.R.TO POLYCYSTIC OVARIAN 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 Anita Mayal |
| Designation |
M.S. Scholar |
| Affiliation |
Madan Mohan Malviya Govt. Ayurved College Udaipur Rajasthan |
| Address |
PG Dept. of Prasuti Tantra & Stree Roga Madan Mohan Malviya Govt. Ayurved College Radaji Circle Ambamata Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
8905046050 |
| Fax |
|
| Email |
anitamayal.11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Narendra Kumar Meena |
| Designation |
Associate Professor & HOD and Guide |
| Affiliation |
Madan Mohan Malviya Govt. Ayurved College Udaipur Rajasthan |
| Address |
PG Dept. of Prasuti Tantra & Stree Roga Madan Mohan Malviya Govt. Ayurved College Radaji Circle Ambamata Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
09950129673 |
| Fax |
|
| Email |
NARENDERMEENA42@YAHOO.COM |
|
Details of Contact Person
Public Query
|
| Name |
Dr Narendra Kumar Meena |
| Designation |
Associate Professor & HOD and Guide |
| Affiliation |
Madan Mohan Malviya Govt. Ayurved College Udaipur Rajasthan |
| Address |
PG Dept. of Prasuti Tantra & Stree Roga Madan Mohan Malviya Govt. Ayurved College Radaji Circle Ambamata Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
09950129673 |
| Fax |
|
| Email |
NARENDERMEENA42@YAHOO.COM |
|
|
Source of Monetary or Material Support
|
| Madan Mohan Malviya Govt Ayurved College Udaipur 313001 Rajasthan India |
|
|
Primary Sponsor
|
| Name |
Madan Mohan Malviya Govt Ayurved College Udaipur Rajasthan |
| Address |
Madan Mohan Malviya Govt Ayurved College Udaipur 313001 Rajasthan India |
| 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 Anita Mayal |
Madan Mohan Malviya Govt Ayurved College Udaipur |
O.P.D. No.-5 Prasuti Tantra & Stree Roga Department Udaipur Rajasthan
Udaipur
RAJASTHAN |
8905046050
anitamayal.11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, Madan Mohan Malviya Govt Ayurved College Udaipur RAJASTHAN |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N914||Secondary oligomenorrhea. 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: Tilmooladi Churna, Reference: Yogratnakar, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: - | | 2 | Intervention Arm | Procedure | - | mAtrAbastiH, मातà¥à¤°à¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Sharangdhar Samhita, Procedure details: 30ml per rectum for 7 days after completion of menses for 3 consecutive menstrual cycle.)
(1) Medicine Name: Lekhaniya Matra Basti, Reference: Sharangdhar Samhita, Route: Rectal, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 90 Days |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Patient willing for the trial
2. P[atient aged between 16 years to 40 years with, fulfilling at least 2 of following 3 criteria:
(American Society for Reproductive Medicine)
i. Patients having polycystic ovary diagnosed by USG.
ii. Patients having Oligomenorrhoea, and or anovulation.
iii.Clinical evidence of Hyperandrogenism. |
|
| ExclusionCriteria |
| Details |
1.â â Patient not willing for trial.
2.â â Patient below age of 16 years and above age of 40 years.
3.â â Patient of amenorrhea with congenital anomalies.
4.â â Cervical tumour, polyp, CA cervix, NC-CAH
5.â â Uterine fibroids, Cushing Syndrome, Thyroid disorders, Hyperprolactinemia.
6.â â Pregnant women.
7.â â Patients having BMI less than 18.5. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in signs and symptoms after treatment |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in other associated symptoms |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
30/12/2024 |
| 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="3"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - None of the above
- Who will be able to view these files?
Response (Others) - nobody
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - NIL
- For how long will this data be available start date provided 20-12-2024 and end date provided 20-12-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This trial study is about to evaluate the efficacy of Tilmooladi Churna and Lekhaniya Matra Basti on Vata-Kaphaja Artavadushti w.s.r. to Polycystic Ovarian Syndrome. There will be a single group of 30 patients. Patients will be treated with Tilmooladi Churna 3 gm BD with lukewarm water and Lekhaniya Matra Basti 30 ml (per rectum) for 7 days for 3 consecutive menstrual cycle. This trial study will be carried out for 3 months. |