| CTRI Number |
CTRI/2025/05/087326 [Registered on: 21/05/2025] Trial Registered Prospectively |
| Last Modified On: |
20/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to see the effect of Rasonadi churn in a menstrual cycle where no egg is released |
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Scientific Title of Study
|
A randomised controlled clinical trial to evaluate the effect of Rasonadi churn in the management of Anovulatory cycle. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aarti Ramesh Jadhav |
| Designation |
PG student |
| Affiliation |
R.A.Podar Medical College (Ayu.),worli,Mumbai |
| Address |
38/303 Nalanda CHS., M. I. G. Colony, RD no. 2,Siddharth nagar, Goregaon west
Mumbai
MAHARASHTRA
400104
India |
| Phone |
8356993648 |
| Fax |
|
| Email |
www.aartijadhav17061999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rutuja Sandeep Gaikwad |
| Designation |
M.S. Prasutitantra evum Streeroga |
| Affiliation |
R.A.Podar Medical College (Ayu.)Worli |
| Address |
R.A.Podar Medical College (ayu.),
Dr.annie Besant Road,
worli,Dadar west,
Mumbai
Mumbai
MAHARASHTRA
400108
India |
| Phone |
9699825626 |
| Fax |
|
| Email |
drrutujasg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rutuja Sandeep Gaikwad |
| Designation |
M.S. Prasutitantra evum Streeroga |
| Affiliation |
R.A.Podar Medical College (Ayu.)Worli |
| Address |
R.A.Podar Medical College (ayu.),
Dr.annie Besant Road,
worli,Dadar west,
Mumbai
Mumbai
MAHARASHTRA
400108
India |
| Phone |
9699825626 |
| Fax |
|
| Email |
drrutujasg@gmail.com |
|
|
Source of Monetary or Material Support
|
| R.A.Podar Medical College (Ayu.) Worli,
Dr. Annie besant road,
Worli, Mumbai 400018
|
|
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Primary Sponsor
|
| Name |
Aarti Ramesh Jadhav |
| Address |
38/303 Nalanda CHS., M. I. G. Colony, Rd. No. 2 Siddharth nagar, Goregaon west, mumbai 400108 |
| Type of Sponsor |
Other [Self] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aarti Ramesh Jadhav |
R.A.Podar edical College(Ayu.),worli |
R.A.Podar Medical College (Ayu.),
Dr.annie Besant Road,
Worli,Dadar west,
Mumbai 400108
Mumbai
MAHARASHTRA |
8356993648
www.aartijadhav17061999@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| R. A. Podar Institutional Ethical Commitee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N970||Female infertility associated withanovulation. Ayurveda Condition: ARTAVADOSHAH/ARTAVADUSHTIH/RAJODOSHAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rasonadi Churna, Reference: Kashayp samhita, kalpsthan, Lashuna kalp adhyaya, sholka number 48, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -go ghrit), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shatavari shatpushpa churn, Reference: Kashyap samhita , kalpa sthan, shatvari shatpusha adhyay, sholka number 4, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -go ghrit), Additional Information: - |
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1-All prediagnosed patients having anovulatory cycle or unruptured ovarian follicle.
2-Married patients
3-Patients having may or may not be associated with PCOS pattern,scanty,regular,irreregular menses |
|
| ExclusionCriteria |
| Details |
1-Patients with Chronic systemic diseases like Diabetes
2-Patients suffering from disoreders of reproductive tract like congenitaldeformities,suspected cases of CA cervix etc
3-Patients with HIV,HbsAg,VDRL positive
4-Uterine synchiae ,uterine fibriods etc.
5-Endometriosis
6-Endometrial carcinoma.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Case Record Numbers |
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Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Rupture of follicle |
8week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1-Folliclar size
2-regularity of menses |
8week |
|
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Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
31/05/2025 |
| 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="2" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Title: "A Randomised Controlled Clinical Trial to Evaluate the Effect of Rasonadi Churna in the Management of Anovulatory Cycle"
INTRODUCTION- The creator of universe has empowered the women to carry out the most noblest work of mankind and that is the work of Reproduction.Numerous factors contribute to infertility, including dietary changes, stress, and a decrease in physical activity that alters menstruation patterns and triggers anovulation.Many patients with these diseases are dissatisfied with the current treatment, which involves hormone therapy. Thus, it’s imperative to treat the anovulation cycle, which eventually leads to infertility, using herbal formulations that have the fewest negative effects and restore the scent of life in women.Thus, there is a great need for study to identify an inexpensive, effective, and less side effect ayurvedic medication for the treatment of vandhyatva. Thus, this study has made an attempt in that regard.In kashyap Samhita kalpa sthan ,in Lasunkalpa adhyaya use of Rasonkalpa in various gynaecological disorders is well explained. Rasona is with Snigdha,Ushna ,tikshna, guru quality and also in katu rasa helps to regulate the menstrual flow and ovarian function.Rasona , twak, tejpatra, shunthi, marich, ela, saindhav with its ushna tikshna guna does deepan and pachan and vatakaphashamak.
RESEARCH QUESTION :- Is Rasonadi churn with ghrut effective in anovulatory cycle ?
HYPOTHESIS :-
Null Hypothesis:- There is no effect of Rasonadi churn with ghrut in anovulatory Cycle.
Alternative Hypothesis:- Rasonadi churn with ghrut is effective in anovulatory cycle.
Aim:- To study the effect of Rasonadi churn with go-ghrit in Anovulatory cycle.
Primary Objective:- To study the Effect of Rasonadi churn with go-ghrit In Anovulatory Cycle.
Secondary Objectives:- 1. To study the effect of Rasonadi churn with go- ghrit on 1.Follicular size 2.Regularity of menses
Methodology:
Design: Randomized controlled trial
Groups:
Group A: Rasonadi Churna with Go-Ghrita
Group B: Shatavari-Shatapushpa Churna with Go-Ghrita (control)
Dose: 5 gms orally, twice daily, from 5th day of menses for 2 consecutive cycles
Sample Size: 35 patients per group
Criteria: Follicular size, ovulation, regularity of menstruation
Assessment Parameters:
Subjective: Menstrual interval, duration
Objective: Follicular rupture, follicle size, ovulation on follicular study
Expected Outcome:
To demonstrate statistically significant improvement in ovulation and menstrual regularity in the Rasonadi Churna group compared to control.
Observation and Results: Observations and results will be drawn according to assessment criteria.
Discussion:- Discussion will be done according to observation table.
Conclusion:- Conclusion will be drawn strictly on basis of statistical analysis and will be unbiased.
Summary:- On the basis of observation and discussion, summery of total clinical trial will be carried out.
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