| CTRI Number |
CTRI/2024/04/066124 [Registered on: 23/04/2024] Trial Registered Prospectively |
| Last Modified On: |
29/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of pre-conceptional ayurvedic protocol in the management
of recurrent pregnancy loss in first trimester |
|
Scientific Title of Study
|
Effect of pre-conceptional ayurvedic protocol in the management
of recurrent pregnancy loss in first trimester: a single arm open labelled clinical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mufeena Jafar |
| Designation |
M. S. Scholar |
| Affiliation |
Institute of Teaching and Research in Ayurveda, Jamnagar |
| Address |
Department of Prasutitantra and Streeroga, 5th floor, Academic building, Institute of Teaching and Research in Ayurveda
Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
8590385524 |
| Fax |
|
| Email |
mufeena.131@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sipika Swati |
| Designation |
Assistant professor |
| Affiliation |
Institute of Teaching and Research in Ayurveda, Jamnagar |
| Address |
Department of Prasutitantra and Streeroga, 5th floor, Academic building, Institute of Teaching and Research in Ayurveda
Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9889501569 |
| Fax |
|
| Email |
drsipikaswatibhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sipika Swati |
| Designation |
Assistant professor |
| Affiliation |
Institute of Teaching and Research in Ayurveda, Jamnagar |
| Address |
Department of Prasutitantra and Streeroga, 5th floor, Academic building, Institute of Teaching and Research in Ayurveda
Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9889501569 |
| Fax |
|
| Email |
drsipikaswatibhu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Teaching and Research in Ayurveda, Opp.B-Division Police Station,Gurudwara Road,Jamnagar,Gujarat 361008 |
|
|
Primary Sponsor
|
| Name |
Institute of Teaching and Research in Ayurveda |
| 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 Mufeena Jafar |
Institute of Teaching and Research in Ayurveda |
Room no. 7, Streeroga OPD, PG Hospital, Institute of Teaching and Research in Ayurveda
Jamnaga, GUJARAT
Jamnagar
GUJARAT |
8590385524
mufeena.131@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 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N96||Recurrent pregnancy loss. Ayurveda Condition: VANDHYA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-करà¥à¤® | (Procedure Reference: Charaka Samhita, Procedure details: Deepana, Pachana with Trikatu Churnawith warm water, BM, (as perKoshtha & Agni) for 5- 7 days
Snehapana with Go- Ghrutha Paana(as per Koshta & Agni) for 3- 7 days upto samyak snigdha lakshana.
whole body Abhyanga with Bala Taila followed by Bashpa Swedana once a day for 4 days
4th day followed by abhyanga and swedana virechana aushadha will be given. Patient will be monitored for whole day. Samsarjana will be advised for 3 to 5 days as per avara/ madhyama/ pravara shuddhi.
)
(1) Medicine Name: Trivrutadi Avaleha, Reference: Ashtanga Hridayam, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 80(g), Frequency: od, Duration: 1 Days | | 2 | Intervention Arm | Procedure | - | mAtrAbastiH, मातà¥à¤°à¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Charaka Samhita, Procedure details: Local abhyanga and swedana followed by Matrabasti)
(1) Medicine Name: Sahacharadi Taila, Reference: Ashtanga hrudayam, Route: Rectal, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 80(g), Frequency: od, Duration: 7 Days | | 3 | Intervention Arm | Procedure | - | uttara-bastiH, उतà¥à¤¤à¤°-बसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Charaka Samhita, Procedure details: Local abhyanga and swedana and yomniprakshalana followed by intra uterine uttara basti)
(1) Medicine Name: Kashmari Kutaja Siddha Ghrutha, Reference: Charaka Samhita, Route: Oral, Dosage Form: Ghrita, Dose: 5(ml), Frequency: od, Duration: 3 Days | | 4 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Prajasthapana Churna, Reference: Charaka Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Milk), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Married females of age between 19 – 40 years having history of two or more
consecutive spontaneous abortion in first trimester with or without children. Patients
will be included minimum after 2 months of last abortion. |
|
| ExclusionCriteria |
| Details |
· Patient with infectious diseases of reproductive tract like tuberculosis, sexually
transmitted diseases, acute PID.
· Organic lesions of reproductive tract like fibroid uterus,carcinoma and congenital
malformation of reproductive tract.
· Patients with history of cardiac diseases, Chronic liver disease, Uncontrolled Diabetes
(≥160 mg/dl- FBS) & Hypertension (Systolic BP ≥160 & Diastolic ≥100 mmHg), TB, etc
· Patient with Hepatitis C, Hepatitis B, HIV
· Patient not eligible for Virechana Karma, Matra BastiandUttara Basti. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
· To promote conception
· To prevent abortion in first trimester |
6-7 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
· To improve endometrial thickness.
· To increase luteal phase length in patients with short luteal phase. |
3 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)
|
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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
Modification(s)
|
INTRODUCTION Recurrent pregnancy loss (RPL), also referred to as recurrent miscarriage or habitual abortion, is 2 or more consecutive pregnancy losses prior to 20 weeks from the last menstrual period. The incidence of RPL is increasing and its management is quite varied and challenging. Management of RPL has to be revised as it requires intervention from Pre-conceptional period itself. Ayurveda gives great importance for the preconception care & Garbhini Paricharya, to ensure a healthy and successful progeny. The present protocol is selected ensuring both Shodhana and Shamana action through Virechana, Matra Basti, Uttara Basti and internal medication. MATERIALS AND METHODS In the present study, minimum 15 diagnosed patients of RPL fulfilling the selection criteria will be registered. Single group of the patients will be treated. In the first cycle Deepana Pachana, Snehapana, Sarvanga Abhyanga & Swedana and Virechana Karma will be performed. In the second cycle Matra Basti with Sahacharadi Taila and Uttara Basti with Kashmari Kutaja Siddha Ghrutha in the third cycle will be performed. Prajasthapana Churna will be given orally in 2nd& 3rd menstrual cycles after the completion of Basti in both cycles. RESULTS AND DISCUSSION Data generated during the above study will be presented in a systemic methodical manner as shall be analysed and the section where the important points of the Conceptual study, Clinical study, Pharmacological study will be discussed. FOLLOW UP Patients will be advised to visit the hospital weekly during treatment. Follow up will be done every 15 days for 2 months after the completion of intervention in every patient. If the patient conceives, follow up will be done for 3 months (during first trimester of pregnancy). After the conception routine Garbhini Paricharya as advised in regular PTSR OPD including checkups, medicines (Bala+Shatavari +Guduchi +Brahmi +Nagkeshara each 1gm morning –evening before food with luke warm milk) USG and laboratory tests will be advised. 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. |