| CTRI Number |
CTRI/2025/03/082464 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
06/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayuevedic management of thin endometrium |
|
Scientific Title of Study
|
Efficacy of Ardhamatrika Yogabasti, Shatapushpadi Taila Uttarbasti and Tila Kwatha orally in the management of Vandhyatva(female infertility) w.s.r. to thin endometrium - A single arm open labelled 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 |
Dr Rinkalben Kantibhai Bumtariya |
| Designation |
M.S. scholar |
| Affiliation |
Institute of Teaching and Reseach in Ayurveda,Jamnagar |
| Address |
Department of Prasutitantra evum Streeroga, fifth floor,Institute building, ITRA Jamnagar, Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
7486855126 |
| Fax |
|
| Email |
rinkalkantibhai@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shilpa Donga |
| Designation |
Professor ,HOD |
| Affiliation |
Institute of Teaching and Reseach in Ayurveda,Jamnagar |
| Address |
Department of Prasutitantra evum Streeroga, fifth floor,Institute building, ITRA Jamnagar, Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
9825646796 |
| Fax |
|
| Email |
drshilpadonga@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shilpa Donga |
| Designation |
Professor ,HOD |
| Affiliation |
Institute of Teaching and Reseach in Ayurveda,Jamnagar |
| Address |
Department of Prasutitantra evum Streeroga, fifth floor,Institute building, ITRA Jamnagar, Gujarat
GUJARAT
361008
India |
| Phone |
9825646796 |
| Fax |
|
| Email |
drshilpadonga@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Institute of Teaching & Research in Ayurveda,INI,Opp.B-Division Police Station, Gurudwara Road, Jamnagar,Gujarat-361008 |
|
|
Primary Sponsor
|
| Name |
Institute of Teaching and Research in Ayurveda |
| Address |
Institute of Teaching & Research in Ayurveda, INI, Opp.B-Division Police,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 Rinkalben Kantibhai Bumtariya |
Institute of Teaching and Research in Ayurveda |
OPD NO:6, Streeroga OPD, Institute of Teaching and Research in Ayurveda,INI,Opp.B-police station, Gurudwara road,Jamnagar-361008
Jamnagar
GUJARAT |
7486855126
rinkalkantibhai@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,Jamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N972||Female infertility of uterine origin. Ayurveda Condition: VANDHYA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Tila Kwatha, Reference: Ashtangahridaya Samhita, Chikitsa Sthana, Gulma Chikitsa Adhyaya, Sutra 120-121, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Vangasena Samhita/ Bastikarmadhikara 90/ 191-196, Procedure details: Ardhamatrika Yogabasti Procedure
Basti will be administered through rectal route before 10 days of expected menstrual date in dose and pattern as below:
Matra Basti (M) with 60ml of Tila Taila
Ardhamatrika Niruha Basti (N) 500ml )
(1) Medicine Name: ardhamatrika Basti, Reference: Vangasena Samhita/ Bastikarmadhikara 90/ 191-196, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 500(ml), Frequency: od, Duration: 3 Days | | 3 | Intervention Arm | Procedure | - | uttara-bastiH, उत्तर-बस्तिः | (Procedure Reference: Kashyap Samhita(Vrddhajivakiya tantra)by Vrddha Jivaka, revised by Vatsya with Sanskrit introduction by Pandit Hemaraja with Vidyotini hindi commentery and hindi translation of Sanskrit introduction by Ayurvedalankar Sri Satyapal Bhisagacharya ,Kalpa Sthan ,Shatpushpa-Shatavari Kalpa Adhyay 5/23-25, Procedure details: After deepan ,pachana ,kostha shodhana and yogabasti then 5 ml uttarabasti of shatapushpadi taila for 6 days will be administered in form of intra uterine uttarbasti(IUUB)once in a day.)
(1) Medicine Name: Shatapushpadi taila, Reference: Kashyap Samhita(Vrddhajivakiya tantra)by Vrddha Jivaka, revised by Vatsya with Sanskrit introduction by Pandit Hemaraja with Vidyotini hindi commentery and hindi translation of Sanskrit introduction by Ayurvedalankar Sri Satyapal Bhisagacharya ,Kalpa Sthan ,Shatpushpa-Shatavari Kalpa Adhyay 5/23-25, Route: Vaginal, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 6 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Female patients having primary or secondary infertility with endometrial thickness less than equal to 7mm diagnosed by TVS with ovulatory cycle and anovulatory cycle, Female patients fit for Basti and Uttarabasti |
|
| ExclusionCriteria |
| Details |
Female patients having infertility due to bilateral tubal blockage, hydro or pyosalpinx, Carcinoma of reproductive tract, Active inflammatory disease, e.g. Acute PID, positive case of HIV, VDRL, HBsAg and HCV, Abnormal uterine anatomy, endometrial tuberculosis, myoma, endometriosis, Patients with history of cardiac diseases, chronic liver disease, uncontrolled hypertension (Systolic BP above 160 & Diastolic above 100 mmHg), uncontrolled diabetes mellitus (above the range of 160 mg/dl - RBS), Female patients contraindicated for Basti and Uttarabasti. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected to increase endometrial thickness |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To correct menstrual irregularities like dysmenorrhoea and scanty menses, To increase the blood flow of uterus by colour doppler study |
10 weeks |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
30/03/2025 |
| 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="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
|
Vandhyatva (Infertility) has been recognized since the Vedic period. Acharya Sushruta has included Vandhya in
Yonivyapadas and Artavavaha Strotasa Viddha Lakshanas. He has described four essential factors for fertility. Ritu
(fertile period), Kshetra (well primed, disease-free endometrial bed), Ambu (sufficient unobstructed blood circulation)
and Beeja (quality spermatozoa from unvitiated, healthy male and quality ovum from disease free, healthy female)
are essential factor for conception. In which uterine factors endometrial abnormalities play a major role in the
causation of infertility. Endometrium forms by the part of Prasada Rasa and Rakta Dhatu and Sthanika Agni. Ruksha
Guna of Vata and Ushna - Tikshna Guna of Pitta are the two main etiological factors affecting endometrium.
Rationality For the Selection of The Topic:
Endometrium plays a major role in establishing a pregnancy and any alteration in this, could be a potential cause for
failure of implantation thus affecting fertility. Extended oestrogen treatment and adjuvant therapy, such as low dose
aspirin, vaginal Sildenafil, etc. are used in modern science for improving endometrium thickness. Still, there isn’t any
proven incidence of this treatment. Other treatments like In-Vitro Fertilization (IVF) - Embryo Transfer (ET), Gamete
Intra Fallopian Transfer (GIFT), etc. are also available. But all these treatments require a healthy endometrium.So this
topic is selected.
Aims and Objective:
To evaluate the efficacy of Ardhamatrika Yogabasti, Shatapushpadi Taila Uttarabasti and Tila Kwatha orally in the
management of Vandhatyva (female infertility) w.s.r. to thin endometrium.
Materials And Methods:
20 patients should fulfill the inclusion criteria for thin endometrium and will be selected in the clinical study.
Follow-up:
Patients will be advised to visit the hospital every 2 weeks during the treatment and for 1 month after the treatment as
a follow-up. Side Effects:
These drugs have no known unwanted effects. It is possible that it may also cause some problems that we are not
aware of. Adverse Drug Reaction if any observed will be reported to the Pharmacovigilance cell of I.T.R.A.,
Jamnagar.
Results: The efficacy of the therapy will be assessed on the basis of subjective and objective criteria.
Benefits: Project will help us to resolve the research question. Collected information from this research project will
be kept confidential, all outcomes will be noted in tabular form and appropriate statistical tests will be applied to
compare the effect. |