CTRI/2024/05/066610 [Registered on: 01/05/2024] Trial Registered Prospectively
Last Modified On:
22/04/2024
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Ayurveda
Study Design
Single Arm Study
Public Title of Study
A clinical study to understand the effect of an ayurvedic treatment in diminished ovarian reserve.
Scientific Title of Study
A single arm study to evaluate the effect of an ayurvedic treatment protocol for the management of diminished ovarian reserve
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
KERALA 690525 India
Kollam KERALA 690525 India
Phone
9495114149
Fax
Email
anjalymvarier@gmail.comA
Details of Contact Person Scientific Query
Name
Dr Hemavathi S K
Designation
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 KERALA 690525 India
Phone
9495114149
Fax
Email
drhemavathi.sk@gmail.com
Details of Contact Person Public Query
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 KERALA 690525 India
Phone
9495114149
Fax
Email
anjalymvarier@gmail.com
Source of Monetary or Material Support
Amrita School of Ayurveda, Amrita Vishwa Vidyapeetham, Amritapuri, Clappana PO, Kollam, PIN 690525, Kerala, 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
NIL
NIL
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
Department of Pasuti tantra and Streeroga, Amrita Vishwa Vidyapeetham, Amritapuri campus, Clappana PO, Kollam - 690525, Kerala, India Kollam
KERALA Kollam KERALA
9495114149
anjalymvarier@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Institutional Ethics Committee Amrita School of Ayurveda
(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: 10(g), Frequency: bd, Duration: 2 Days
2
Intervention Arm
Procedure
-
dIpana , दीपन
(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: 10(g), Frequency: bd, Duration: 2 Days
3
Intervention Arm
Procedure
-
aCasnehaH, अचà¥à¤›à¤¸à¥à¤¨à¥‡à¤¹à¤ƒ
(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 and koá¹£á¹ha (Digestion) of participant) (1) Medicine Name: Mahanarayana Taila,, Reference: Sahasrayoga, Route: Oral, Dosage Form: Ghrita, 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
4
Intervention Arm
Procedure
-
svedanam, सà¥à¤µà¥‡à¤¦à¤¨à¤®à¥
(Procedure Reference: Ashtanga Hridaya, Procedure details: Abhyanga and 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
(Procedure Reference: Ashtanga Hridaya, Procedure details: Mridu Vamana or Virechana will be done according to the patient condition. Virechana will be done with Avipathy Churna 30g at preferably 7 am after snehana and svedana) (1) Medicine Name: Avipathy churna, Reference: Sahasrayoga, Route: Oral, Dosage Form: Churna/ Powder, Dose: 30(g), Frequency: od, Duration: 1 Days
6
Intervention Arm
Procedure
-
yoga-bastiH, योग-बसà¥à¤¤à¤¿à¤ƒ
(Procedure Reference: Charaka Samhita, Procedure details: NirÅ«habasti with 750 ml of Mustadiyapanabasti and AnuvÄsanabasti with 150 ml of MahÄnÄrayaṇataila) (1) Medicine Name: Mahanarayana Taila, Reference: Sahasrayoga, Route: Rectal, Dosage Form: Taila, Dose: 150(ml), Frequency: od, Duration: 5 Days
(Procedure Reference: Ashtanga Hridaya, Procedure details: With 3 ml MahÄnÄrayaṇataila into the uterine cavity on the day of Niruha vasti) (1) Medicine Name: Mahanarayana Taila, Reference: Sahasrayoga, Route: Vaginal, Dosage Form: Taila, Dose: 3(ml), Frequency: od, Duration: 3 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 less than 1.1 ng/ml, AFC less than 7 follicles
3)Participants with regular menstruation associated with either scanty menstruation or vaginal dryness or hot flashes
or other peri menopausal symptoms
ExclusionCriteria
Details
1)Diagnosed of genetic disorders
2)Undergoing treatment for malignancy
3)Undergoing treatment for systemic pathologies like DM, HTN, HDL
4)History of oophorectomy
5)Known case of Poly cystic ovarian syndrome
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 three months of Ayurvedic treatment.
Secondary Outcome
Outcome
TimePoints
1)Assessment of menstrual cycle in terms of Frequency, Duration, and Volume
2)Vaginal dryness or vaginal pain
Assessment will be done during recruitment, on every visit and post assessment after three months of Ayurvedic treatment
Target Sample Size
Total Sample Size="24" Sample Size from India="24" 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)
10/05/2024
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="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
Diminished ovarian reserve patients have low Anti Mullerian Hormone (AMH) values and Antral Follicle Count (AFC).An Ayurveda treatment protocol based on Artava kshaya chikitsa found clinically improving Anti Mullerian Hormone (AMH) and Antral Follicle Count (AFC).Hence the role of Ayurveda in managing DOR by improving either AMH value or AFC must be studied and validated. In the future, it will benefit DOR patients to have ART procedures with their eggs and thus opening a wide scope for research in integrated medicine. The patients who opt for natural pregnancy also benefit as it improves the quality and quantity of oocytes. Also, it benefits the patients by improving their overall menstrual health. Hence the specific Ayurvedic treatment protocol mentioned for Artavakshaya chikitsa can be tested for its efficacy in managing Diminished Ovarian Reserve.
The aim of this single arm study is to evaluate the effect of an Ayurveda treatment protocol in 25- 40-year-old Diminished Ovarian Reserve patients. For this 24 patients satisfying inclusion and exclusion criteria will be recruited to the study. The primary outcome measure is improvement of serum anti-Mullerian hormone (AMH) level and Improvement of Ultrasonography count of ovarian antral follicles, Antral follicle count (AFC) which will be assessed before and after treatment. Secondary outcome measure is to assess in every visit the change in Menstrual cycle pattern in terms of frequency, quantity and duration an change in Vaginal dryness / pain.