CTRI/2023/11/059872 [Registered on: 15/11/2023] Trial Registered Prospectively
Last Modified On:
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Ayurveda
Study Design
Single Arm Study
Public Title of Study
A study to evaluate the effect of an ayurvedic treatment protocol prior to in vitro fertilization in women with diminished ovarian reserve and understanding the molecular mechanisms involved.
Scientific Title of Study
Role of an ayurvedic treatment protocol as a prerequisite for in vitro fertilization in women with diminished ovarian reserve: elucidating mechanistic insights incorporating multi-omics approaches
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 Anjaly MV
Designation
Associate Professor
Affiliation
Amrita School of Ayurveda
Address
Department of Prasuti tantra and Stree roga
Amrita School of Ayurveda
Amrita Vishwa Vidyapeetham
Amritapuri campus
Clappana PO, Kollam - 690525
Kerala
Kollam KERALA 690525 India
Phone
9495114149
Fax
Email
anjalymvarier@gmail.com
Details of Contact Person Scientific Query
Name
Dr Muralidharan V
Designation
Assistant Professor
Affiliation
Amrita School of Biotechnology
Address
Amrita School of Biotechnology
Amrita Vishwa Vidyapeetham
Amritapuri campus
Clappana PO, Kollam - 690525
Kerala
Kollam KERALA 690525 India
Phone
8589083013
Fax
Email
muralidharanv89@gmail.com
Details of Contact Person Public Query
Name
Dr Muralidharan V
Designation
Assistant Professor
Affiliation
Amrita School of Biotechnology
Address
Amrita School of Biotechnology
Amrita Vishwa Vidyapeetham
Amritapuri campus
Clappana PO, Kollam - 690525
Kerala
Kollam KERALA 690525 India
Phone
8589083013
Fax
Email
muralidharanv89@gmail.com
Source of Monetary or Material Support
Amrita Institute of Medical Sciences, Amrita Vishwa Vidyapeetham, Ponekkara P.O. Kochi, Kerala 682 041, India
Amrita School of Ayurveda, Amrita Vishwa Vidyapeetham, Amritapuri campus, Clappana PO, Kollam - 690525, Kerala, India
Amrita School of Biotechnology, Amrita Vishwa Vidyapeetham, Amritapuri campus, Clappana PO, Kollam - 690525, Kerala, India
Indian Council of Medical Research, Department of Health Research, Ministry of Health & Family Welfare Government of India, Ansari Nagar, New Delhi - 110029, India
Primary Sponsor
Name
Amrita School of Ayurveda
Address
Amrita School of Ayurveda, Amrita Vishwa Vidyapeetham, Amritapuri campus, Clappana PO, Kollam - 690525, Kerala, India
Type of Sponsor
Private medical college
Details of Secondary Sponsor
Name
Address
Amrita Institute of Medical Sciences
Department of Reproductive Medicine, Amrita Institute of Medical Sciences, Amrita Vishwa Vidyapeetham, Ponekkara P.O. Kochi, Kerala 682 041, India
Amrita School of Biotechnology
Amrita School of Biotechnology, Amrita Vishwa Vidyapeetham, Amritapuri campus, Clappana PO, Kollam - 690525, Kerala, India
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Anjaly MV
Amrita School of Ayurveda
Amrita Vishwa Vidyapeetham, Amritapuri campus, Clappana PO, Kollam - 690525, Kerala, India Kollam KERALA
9495114149
anjalymvarier@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Amrita Institute of Medical Sciences Institutional Ethics Committee
(Procedure Reference: Ashtanga Hridaya, Procedure details: 3 - 5 ml of MahÄnÄrayaṇataila will be introduced into the uterine cavity on the day of Niruha vasti) (1) Medicine Name: Mahanarayana Taila, Reference: Sahasrayoga, Route: Vaginal, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 3 Days
2
Intervention Arm
Procedure
-
yoga-bastiH, योग-बसà¥à¤¤à¤¿à¤ƒ
(Procedure Reference: Charaka Samhita, Procedure details: NirÅ«habasti with 750 ml of Mustadiyapanabasti & AnuvÄsanabasti with 150 ml of MahÄnÄrayaṇataila will be done on alternate days) (1) Medicine Name: Mahanarayana Taila, Reference: Sahasrayoga, Route: Rectal, Dosage Form: Taila, Dose: 150(ml), Frequency: od, Duration: 5 Days
3
Intervention Arm
Procedure
-
aBya~ggaH, अà¤à¥à¤¯à¤‚गÂ
(Procedure Reference: Ashtanga Hridaya, Procedure details: Abhyanga & svedana will be done for three days with Dhanwantara taila) (1) Medicine Name: Dhanwantara taila, Reference: Ashtanga Hridaya, Route: Topical, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 3 Days
4
Intervention Arm
Procedure
-
svedanam, सà¥à¤µà¥‡à¤¦à¤¨à¤®à¥
(Procedure Reference: Ashtanga Hridaya, Procedure details: Following Abhyanga Svedana will be done as a purva karma of shodhana) (1) Medicine Name: Dhanwantara taila, Reference: Ashtanga Hridaya, Route: Topical, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 3 Days
(Procedure Reference: Ashtanga Hridaya, Procedure details: Mridu Vamana will be done according to the patient condition.) (1) Medicine Name: Yashtimadhu, Madana phala, vacha, Reference: Susrutha Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: od, Duration: 1 Days
6
Intervention Arm
Procedure
-
virecana-karma, विरेचन-करà¥à¤®
(Procedure Reference: Ashtanga Hridaya, Procedure details: Virechana will be done with Avipathy Churna 30g at preferably 7 am after snehana & svedana) (1) Medicine Name: Avipathy churna, Reference: Sahasrayoga, Route: Oral, Dosage Form: Churna/ Powder, Dose: 30(g), Frequency: od, Duration: 1 Days
7
Intervention Arm
Procedure
-
dIpana , दीपन
(Procedure Reference: Ashtanga Hridaya, Procedure details: As a purva karma of Shodhana, 5g of Vaiswanara churna will be given twice daily before food with warm water for a maximum of two days)) (1) Medicine Name: Vaiswanara Churna, Reference: Sahasrayoga, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Duration: 2 Days
8
Intervention Arm
Procedure
-
pAcana, पाचन
(Procedure Reference: Ashtanga Hridaya, Procedure details: As a purva karma of Shodhana, 5g of Vaiswanara chirna will be given twice daily before food with warm water for a maximum of two days)
) (1) Medicine Name: Vaiswanara Churna, Reference: Sahasrayoga, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Duration: 2 Days
(Procedure Reference: Ashtanga Hridaya, Procedure details: Shodhananga SnehapÄna with appropriate ghee or oil. Ä€rohaṇakrama (Escalation of dose) will be done after assessing the Agni & koá¹£á¹ha (Digestion) of participant) (1) Medicine Name: Mahanarayana Taila, Reference: Sahasrayoga, Route: Oral, Dosage Form: Taila, Dose: 25(ml), Frequency: od, Duration: 7 Days(2) Medicine Name: Kalyanaka Gritha, Reference: Ashtanga Hridaya, Route: Oral, Dosage Form: Ghrita, Dose: 25(ml), Frequency: od, Duration: 7 Days(3) Medicine Name: Phalasarpi, Reference: Ashtanga Hridaya, Route: Oral, Dosage Form: Ghrita, Dose: 25(ml), Frequency: od, Duration: 7 Days
Inclusion Criteria
Age From
25.00 Year(s)
Age To
40.00 Year(s)
Gender
Female
Details
1)Participant willing and able to give informed consent for participation in the trial.
2)Diagnosed with Diminished ovarian reserve (serum AMH <1.1 ng/ml, AFC < 7 follicles)
3)Poor ovarian response in the prior IVF cycle
ExclusionCriteria
Details
1)Diagnosed of genetic disorders
2)Undergoing treatment for malignancy
3)History of oophorectomy
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
1) Improvement in Ultrasonography count of ovarian antral follicles, Antral follicle count (AFC) - on Day 2/3 of the menstrual cycle
2)Improvement in serum anti-Mullerian hormone (AMH) – Day 2/3 of the Menstrual Cycle
Assessment before treatment (BT) will be done during recruitment and post assessment after treatment (AT) will be done after two months of Ayurvedic treatment.
Secondary Outcome
Outcome
TimePoints
Multi omics analysis of follicular fluid - (Treatment group - 10; after two months of Ayurveda treatment and Control group - 10).
On the day of oocyte retrieval during In Vitro fertilization.
Target Sample Size
Total Sample Size="40" Sample Size from India="40" 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)
01/02/2024
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="3" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Open to Recruitment
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
The trial is designed as single arm pre-and post- clinical study. Study setting - Amrita Fertility Centre and Amrita School of Ayurveda, Amrita Vishwa Vidyapeetham.
Women diagnosed with DOR (AFC <5–7 follicles and AMH <0.5–1.1 ng/ml) undergoing IVF cycles will be screened at Amrita Fertility Centre. After due consent, these patients will be subjected to Ayurvedic treatment protocol at Amrita School of Ayurveda. Assessment criteria - Serum AMH and Ultrasonography count of ovarian Antral Follicle on Day 2/3 of the menstrual cycle. Intervention at Amrita School of Ayurveda - The therapeutic plan will be initially performed through Sodhana cikitsa (cleansing therapy), during which the patient will be admitted to the hospital for 21 days. It will be followed by Shamana cikitsa (oral medication) for 1 month. Sodhana chikitsa includes Accha Snehapāna (intake of oil/ghee) and Mridu Vamana/Virechana (emesis/purgation). In the final phase, the patient will be subjected to Yoga Basti and Uttara Basti (medicated enema through the anal route and vagina). After completing shodhana chikitsa shamana chikitsa will be done. After undergoing Ayurveda treatment for two months, participants will be sent back to Amrita Fertility Centre for post- assessment and further fertility treatments, during which follicular fluid will be collected for multi-omics analysis.
Study tools -Ultrasonography count of ovarian antral follicles, Antral follicle count (AFC) on Day 2/3 of menstrual cycle and Serum test of anti-Mullerian hormone (AMH) on Day 2/3 of menstrual cycle
Sample size - 40 women diagnosed with DOR satisfying inclusion and exclusion criteria after consent will be recruited to the study for Ayurvedic treatment protocol, Follicular fluid will be collected from 20 patients for multi-omics analysis (Treatment group - 10 and Control group - 10)
Study Interventions
Treatment protocol and Interventions – Sodhana chikitsa
Treatment procedure
Method of administration
Treatment duration
Dipana, pacana with Vaisvanara churna (preparatory procedure)
5g twice daily before food with warm water
Day 1–2
Snehapana with appropriate ghee or oil
Arohanakrama (Escalation of dose) after assessing the Agni and koshta (Digestion)
Day 3–8
Snehana and svedana (Oleation and sweating treatment)
Sarvanga abhyanga (whole body massage)with Dhanvantara taila followed by nadi sveda (sweating treatment)
Day 9 – 11
Mridu vamana or
Mriduvirecana with Avipatti choorna
30 g given at 7 am
Day 10 or
Day 11
Yogabasti (medicated enema through anal route)
Niruhabasti with 750 ml of Mustadiyapanabasti and Anuvasanabasti with 150 ml of Mahanarayana taila
Day 13–20
Uttarabasti (medicated enema through vaginal route)
With 3 ml Mahanarayana taila into the uterine cavity on the day of Niruha vasti