| CTRI Number |
CTRI/2025/02/080491 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
11/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Ayurvedic medicines during pregnancy on well being of mother and baby |
|
Scientific Title of Study
|
IMPACT OF AYURVEDIC MONTHWISE MEDICINAL REGIMEN IN ANTENATAL CARE ON PREGNANCY AND ITS OUTCOME:AN OPEN LABEL PILOT 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 |
Dr Priya Tyagi |
| Designation |
PG Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Department of Stri Roga Evam Prasuti Tantra 4th floor Academic Block All India Institute of Ayurveda Mathura Road Gautam Puri Sarita Vihar delhi 110076
South
DELHI
110076
India |
| Phone |
8447196431 |
| Fax |
|
| Email |
priyatyagi98dr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meenakshi Pandey |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Department of Stri Roga Evam Prasuti Tantra 4th floor Academic Block All India Institute of Ayurveda Mathura Road Gautam Puri Sarita Vihar delhi 110076
South
DELHI
110076
India |
| Phone |
7905824977 |
| Fax |
|
| Email |
drmeenakshipathak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meenakshi Pandey |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Department of Stri Roga Evam Prasuti Tantra 4th floor Academic Block All India Institute of Ayurveda Mathura Road Gautam Puri Sarita Vihar delhi 110076
South
DELHI
110076
India |
| Phone |
7905824977 |
| Fax |
|
| Email |
drmeenakshipathak@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Ayurveda |
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF AYURVEDA |
| Address |
MATHURA ROAD GAUYAMPURI SARITA VIHAR DELHI -110076 |
| Type of Sponsor |
Government medical college |
|
|
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 Meenakshi Pathak |
All India Institute of Ayurveda |
Department of Stri Roga Evam Prasuti Tantra, Room No 401, Fourth Floor, Academic Block, AIIA, Mathura Road, Gautam Puri, Sarita Vihar, Delhi 110076
South West
DELHI |
7905824977
drmeenakshipathak@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Division of Translational Reseach and Biostatistics |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pregnant women of age group 18-35 years |
| Patients |
(1) ICD-10 Condition:O251||Malnutrition in pregnancy. Ayurveda Condition: GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Phala ghrita, Reference: Tripathi B. Ashtanga Hridayam. 2014 edition. Varanasi: Chaukhamba Sanskrit Sansthan; 2014. Uttarsthana, 34/63b-67.p.1142, Route: Oral, Dosage Form: Ghrita, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: milk), Additional Information: medicine will be given for 1st 12 weeks of preganancy | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dhatri lauh, Reference: Govinda Dasji Bhisaratna Bhaishajya Ratnavali. Delhi: Chaukhambha Publications; [2019]. Panduroga Chikitsa, 12/30. p.378., Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Months, anupAna/sahapAna: Yes(details: water), Additional Information: Medicine will be given from 9th week of pregnancy till delivery | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dadimadi ghrita, Reference: Kashinath P, Gorakhnath P. Charak Chikitsa. 2015 reprint ed. Varanasi: Chaukhamba Bharti Academy; 2015. Panduroga Chikitsa, verse 44-46. p. 494, Route: Oral, Dosage Form: Ghrita, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: milk), Additional Information: medicine will be given starting from 16th week of pregnancy till 20 weeks of pregnancy | | 4 | Intervention Arm | Procedure | - | AsthApana-bastiआस्थापन-बस्ति | (Procedure Reference: Sushruta Samhita,edited by Ambika Dutta Shastri ,Sharissthan,10/4.Varanasi:Chaukhamba Sanskrit Sansthan;reprint 2014, Procedure details: 1 Asthapan basti with badaradi kashay 450 ml once .)
(1) Medicine Name: Badaradi kashay, Reference: Sushruta Samhita,edited by Ambika Dutta Shastri ,Sharissthan,10/4.Varanasi:Chaukhamba Sanskrit Sansthan;reprint 2014,, Route: Rectal, Dosage Form: Not Applicable, Dose: 450(ml), Frequency: od, Duration: 1 Days | | 5 | Intervention Arm | Procedure | - | mAtrAbasti मात्राबस्ति | (Procedure Reference: Charaka. Charaka Samhita. Pt. Rajeswara Datta Shastri, Editor. sutra sthana 4/1-2, Chaukhambha Bharati Academy, Varanasi, Reprinted 2015, Procedure details: matra basti with bala tail once daily for 9 days))
(1) Medicine Name: Bala tail, Reference: Nishteswar K, Vidyanath R, editors. Sahasrayogam. Fourth Edition. Varanasi: Chaukhamba Sanskrit Series Office; 2014. p. 110., Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 9 Days | | 6 | Intervention Arm | Drug | Classical | | | | 7 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shatavari churna, Reference: Sharma P. Dravya Guna Vigyan. Part II. Varanasi: Chaukhamba Bharti Academy; 2005. p. 562., Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 16 Weeks, anupAna/sahapAna: Yes(details: water), Additional Information: medicine will be given for 1st 16 weeks of pregnancy | | 8 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Muktashukti pishti, Reference: Gautam DS. Rasatarangini. Varanasi: Chaukhamba Surbharti Prakashan; 2022. Dwadash Tarang, Shankhadivigyaneeya, 68-70. p. 275., Route: Oral, Dosage Form: Pishti, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Months, anupAna/sahapAna: Yes(details: -water), Additional Information: -Medicine will be given from 9th week of pregnancy till delivery | | 9 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Prithakparnayadi ghrita, Reference: Shastri AD. Sushrut Samhita. Varanasi: Chaukhamba Sanskrit Sansthan; 2016. Sharir Sthan, Adhyaya 10, Garbhini Vyakaran Sharir, verse 4. p. 99, Route: Oral, Dosage Form: Ghrita, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: milk), Additional Information: medicine will be given starting from 24th week of pregnancy till 28 weeks of pregnancy | | 10 | Intervention Arm | Procedure | - | aByanggaH, अभ्यंग | (Procedure Reference: none, Procedure details: Mridu aByanggaH, by self with Bala Tail)
(1) Medicine Name: Bala tail, Reference: Nishteswar K, Vidyanath R, editors. Sahasrayogam. Fourth Edition. Varanasi: Chaukhamba Sanskrit Series Office; 2014. p. 110., Route: Topical, Dosage Form: Taila, Dose: 1(NA), Frequency: od, Duration: 4 Months |
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Primi and second gravida as soon as possible after confirmation of pregnancy by Ultrasonography.
Age group 18-35 years.
Able and willing to participate and provide signed informed consent.
|
|
| ExclusionCriteria |
| Details |
Severe anaemia Hb is less than 8 gm/dl.
Pregnancy complicated by placenta previa, coexisting fibroid, any malignancy, Twin pregnancy.
Pregnancy associated with systemic diseases such as hypo or hyperthyroidism, cardiovascular diseases, diabetes mellitus, renal disease
Pregnancy associated with any suspected obstetric complications such as partial hydatidiform mole, vaginal bleeding
History of repeated abortions /premature birth / still birth /and undergoes last delivery by caesarean section |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome: The study will evaluate the impact of ayurvedic month wise medicinal regimen on mode of delivery. |
Primary outcome: The study will evaluate the impact of ayurvedic month wise medicinal regimen on mode of delivery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcome: The study will evaluate the Impact of ayurvedic month wise medicinal regimen on feto maternal wellbeing |
Baseline,36weeks,after delivery |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
25/02/2025 |
| 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="0"
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
|
RESEARCH QUESTION: What is the impact of ayurvedic month wise medicinal regimen in ante natal care on pregnancy and its outcome? HYPOTHESIS: Ayurvedic month wise medicinal regimen in antenatal care is effective in pregnancy and its outcome. |