| CTRI Number |
CTRI/2024/05/066883 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
01/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An Ayurvedic treatment protocol for the management of female infertility (Vandhytava) due to low anti-mullerian harmone |
|
Scientific Title of Study
|
Efficacy of Virechana,Shatpushpa Yapana Basti,Phalkalyan Ghrita Uttara Basti,Shatpuspa Taila Nasya along with Lakshmana Churna orally in the management of female infertility (Vandhytava) w.s.r. to low AMH - An open labelled single arm clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kusum Kumari |
| Designation |
M.S. scholar |
| Affiliation |
Institute of Teaching and Research in Ayurveda, Jamnagar. |
| Address |
Department of prasuti tantra evum stree roga,5th floor, academic building, Institute of teaching and research in ayurveda, Jamnagar.
Jamnagar GUJARAT 361008 India |
| Phone |
7073076929 |
| Fax |
|
| Email |
kusumrangi245@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
vd Grishma Solanki |
| Designation |
Lecturer |
| Affiliation |
Institute of Teaching and Research in Ayurveda, Jamnagar |
| Address |
Department of Prasuti Tantra Evum Stree Roga, 5th floor academic building, Institute of Teaching and Research in Ayurveda, Jamnagar
Jamnagar GUJARAT 361008 India |
| Phone |
9427753900 |
| Fax |
|
| Email |
grishmabams@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
vd Grishma Solanki |
| Designation |
Lecturer |
| Affiliation |
Institute of Teaching and Research in Ayurveda, Jamnagar |
| Address |
Department of Prasuti Tantra Evum Stree Roga, 5th floor academic building, Institute of Teaching and Research in Ayurveda, Jamnagar
GUJARAT 361008 India |
| Phone |
9427753900 |
| Fax |
|
| Email |
grishmabams@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Teaching and Research in Ayurveda, Jamnagar |
|
|
Primary Sponsor
|
| Name |
Institute of Teaching and Research in Ayurveda, Jamnagar |
| Address |
Opp. B-Division Police Station, Gurudwara Road Jamnagar, Gujarat 361008 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Kusum Kumari |
PG Hospital, Institute of Teaching and Research in Ayurveda Jamnagar |
OPD no.07, PG Hospital, Institute of Teaching and Research in Ayurveda Jamnagar, GUJARAT Jamnagar GUJARAT |
7073076929
kusumrangi245@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Institute of Teaching and Research in Ayurveda, Jamanagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N978||Female infertility of other origin. Ayurveda Condition: VANDHYA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | uttara-bastiH, उतà¥à¤¤à¤°-बसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Chakrapani Charak Siddhi, Procedure details: Local Abhyanga & Swedana at Kati, Prushtha and Adhodara Pradesha, Yoniprakshalana With Triphala kwath Uttara Basti.This procedure will be done for 6 days once in a Day.) (1) Medicine Name: Phalakalyana Ghrita Uttarbasti, Reference: : Bhaishajya Ratnawali Yonivyapada Chikitsa, , Route: Vaginal, Dosage Form: Ghrita, Dose: 5(ml), Frequency: od, Duration: 6 Days | | 2 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Charak Siddhi Sthana, Procedure details: Local Abhyanaga & Swedana at Urdhwajatrugata Pradesha, Nasya Karma.This Procedure will be done for 2 Consecutive cycle. 8 Drop in each nostrils.) (1) Medicine Name: Shatapushpa Taila , Reference: Sharangdhara Samhita Madhyama Khanda , Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 7 Days | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Lakshmana Churna, Reference: Yoga Ratnakar Yonivyapada Chikitsa, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 5 Months, anupAna/sahapAna: Yes(details: -Go- Dugdh), Additional Information: -All the interventions are given in single group. | | 4 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-करà¥à¤® | (Procedure Reference: Kashyapa Samhita Siddhi Sthana, Procedure details: Deepan Pachan for 5 to 7 days, Snehpana with Go-ghrit As per koshtha & agni, Abhayang and swedan for 4 days, virechana karma for 1 day ,sansarjana karma as per koshtha sudhi )) (1) Medicine Name: Trivruta Avalaha, Reference: Ashtang Hridaya kalpa sthan 2/9, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 80(g), Frequency: od, Duration: 1 Days | | 5 | Intervention Arm | Procedure | - | yApana-bastiH, यापन-बसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Charak Samhita Sidhi Sthana, Procedure details: Sthanik Abhayang & Swedan at Adhoudara,and Kati Pradesh, Yapan Basti. This procedure will be done for 7 days empty stomach in the morning ) (1) Medicine Name: Shatpushpa Yapana Basti, Reference: Charak Samhita Sidhi Sthana, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 650(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Married female patients of reproductive age 20-
40 years with complain of infertility.
2.Patients with AMH level less than 2.2
3.Patients with AFC less than 8
4.Patients eligible for Virechana, Yapan Basti,
Uttar Basti and Nasya Karma.
Patients willing to participate in trial.
|
|
| ExclusionCriteria |
| Details |
1.Unmarried female patients of reproductive age
below 20 and above 40.
2.Patients with AMH more than or equal to 2.2
3.Patient with AFC more than or equal to 8
4.Patients are not eligible and willing for
procedure
Patients willing to participate in trial.
Suffering from malignancies and chronic systemic diseases like, uncontrolled hypertension (Systolic blood pressure above 160 & Diastolic blood pressure above 100mmhg), uncontrolled diabetes (above the range of 160-200 mg/dl (RBS), Hepatitis C, Hepatitis B etc..
Patient with infectious diseases of the reproductive tract like tuberculosis and sexually transmitted diseases.
Patient with polycystic ovarian syndrome (PCOS).
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in the level of AMH.
Improvement in the AFC.
|
5 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Correct menstrual abnormality.
induce ovulation
Achieve conception
|
5 months |
|
|
Target Sample Size
|
Total Sample Size="15" Sample Size from India="15"
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)
|
15/05/2024 |
| 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="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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:-
Infertility is
defined as not being able to get pregnant or conceive after one year or longer
time period of unprotected vaginal intercourse.
The most common
overall cause of female infertility is the failure to ovulate, which occurs in
40% of women with infertility issues.
Poor Ovarian
Reserve (POR) indicates a reduction in the quantity of ovarian follicular pool
in women of reproductive age group and it is an important cause of infertility
due to failure to ovulate in many couples.
Anti Mullerian
Hormone (AMH) is considered as a marker for the ovarian reserve, as it has a
regulative function in the activation of folliculogenesis and has an influence
on atresia rate.
In women, an AMH
level can provide information about the fertility status and the ability to get
pregnant. The term ovarian reserve describes the number and the quantity
of the remaining oocytes in the
follicles.
According to
Acharya Sushruta, there are four factors responsible for creation of Garbha i.e.
Rutu (ovulatory period/ period for copulation), Kshetra (reproductive
tract including uterus, fallopian tube, ovary), Ambu (nutritive fluid
for fertilized ovum), Beeja (Shukra & Shonita i.e.
sperm & ovum). Among these four factors low AMH can be considered as the
deformity of Beeja i.e. Beejadusti. Beeja is the corestone
of female reproductive process and in its absence conception cannot achieve
despite of all other factors, here Beeja is taken as Antahpushpa i.e.,
ovum.
Rationale for
selection of the topic
AMH level is
indicative of ovarian response, its measurement becomes an inevitable criteria
before IVF. Considering the high cost and possible complications of ART
procedures, the unavoidable role of AMH as a superior candidate predicting
ovarian reserve has been explored in various studies.
Therefore,
uncertainty in the ART procedure outcome can be minimized to a greater extent. Reports
suggest that patients with a diminished ovarian reserve have the only option of
IVF with a donor egg. The occurrence of poor ovarian response in IVF
ranges from10 to 20%.
The clinical
symptoms observed in the infertility with low AMH resembles to Dhatukshayajanya
Vandhyatva (infertility due to depletion of body tissues), that has been
already explained in Ayurveda in Harita Samhita.
The role of an
effective Ayurvedic treatment protocol to improve the AMH level to a
satisfactory level to have a better response to ovarian stimulation for normal
conception or IVF by own eggs, thereby opening a scope of an integrated medical
approach. The present study is an attempt on the same
AIM :-
To evaluate the
efficacy of Virechana, Shatpushpa Yapana Basti, Uttara Basti with Phalakalyan
Ghrita, Nasya with Shatapushpa Taila along with oral
administration of Lakshmana Choorna in the management of female
infertility (Vandhytava) due to low AMH.
Objectives:
To evaluate the
effect of trial drug in improving the
AMH (Anti Mullerian Hormone) level.
To evaluate the
effect of trial drug in improving the AFC (Antral Follicle Count).
Materials and Methods
In this study there is only one group containing 15
patients and will be treated with in first month Virechana Karma will be
done.In second month Shatpushpa Yapan Basti (7 days) will be
done.In third month Phalkalyan Ghrita Uttarbasti (6 days) will be done.In
forth and fifth month Shatpushpa Taila Nasya ( 7 days and will repeat
this for 2 consecutive ctyclcles) will
be done along with Lakshamana Choorna orally for 5 month.
Results and Discussion:
Data generated during the above study will be
presented in a systemic manner and shall be analysed statistically. The
important points of the Conceptual study, Analytical study, Pharmacological
study will be discussed.
Side Effects: This drug has no known unwanted effects.
Adverse Drug Reaction if any observed will be reported to the Pharmacovigilance
cell of I.T.R.A., Jamnagar. |