| CTRI Number |
CTRI/2024/11/077379 [Registered on: 27/11/2024] Trial Registered Prospectively |
| Last Modified On: |
10/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative clinical study of prajasthapanamahakashaya granules and jeevaniyamahakashaya granules in prevention of abortion |
|
Scientific Title of Study
|
A Randomized comparative clinical study of prajasthapanamahakashaya granules and jeevaniyamahakashaya granules in prevention of garbhasrav (early pregnancy loss) |
| 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 Anjali Jain |
| Designation |
Ph.D. Scholar |
| Affiliation |
National Institute of Ayurveda(De Novo) Jaipur |
| Address |
PG DEPARTMENT OF STREE EVAM PRASOOTI TANTRA NATIONAL INSTITUTE OF AYURVEDA (De Novo) JAIPUR
Jaipur
RAJASTHAN
302002
India |
| Phone |
8440836606 |
| Fax |
|
| Email |
anjalijain1807@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anjali Jain |
| Designation |
Ph.D. Scholar |
| Affiliation |
National Institute of Ayurveda(De Novo) Jaipur |
| Address |
PG DEPARTMENT OF STREE EVAM PRASOOTI TANTRA NATIONAL INSTITUTE OF AYURVEDA(De Novo) JAIPUR
Jaipur
RAJASTHAN
302002
India |
| Phone |
8440836606 |
| Fax |
|
| Email |
anjalijain1807@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anjali Jain |
| Designation |
Ph.D. Scholar |
| Affiliation |
National Institute of Ayurveda(De Novo) Jaipur |
| Address |
PG DEPARTMENT OF STREE EVAM PRASOOTI TANTRA NATIONAL INSTITUTE OF AYURVEDA (De Novo) JAIPUR
Jaipur
RAJASTHAN
302002
India |
| Phone |
8440836606 |
| Fax |
|
| Email |
anjalijain1807@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda |
|
|
Primary Sponsor
|
| Name |
DR ANJALI JAIN |
| Address |
PG DEPARTMENT OF STREE EVAM PRASOOTITANTRA NATIONAL INSTITUTE OF AYURVEDA (De Novo)JAIPUR |
| Type of Sponsor |
Other [NATIONAL INSTITUTE ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Prof B Pushpalatha |
PG DEPARTMENT OF STREE EVAM PRASOOTITANTRA NATIONAL INSTITUTE OF AYURVEDA (De Novo)JAIPUR |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anjali Jain |
National Institute of Ayurveda(De Novo) Jaipur |
PG DEPARTMENT OF STREE EVAM PRASOOTI TANTRA, NATIONAL INSTITUTE OF AYURVEDA(De Novo) JAIPUR
Jaipur
RAJASTHAN |
8440836606
anjalijain1807@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Ayurveda(De Novo) Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O090||Supervision of pregnancy with history of infertility. Ayurveda Condition: GARBASRAVAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Prajasthapana Mahakashaya, Reference: Charak Samhita Sutra Sthana 4/18/49, Route: Oral, Dosage Form: Khanda /Granules, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: cowmilk), Additional Information: along with Vatashunga
Dose – 4 drops (in right or left nostrils randomly)
Dose Form – swaras (8 Vatashunga mixed with unboiled cow milk)
Time of administration – morning in empty stomach
Route of administration- nasal route
Duration- 2 sittings ( first sitting on the day after pregnancy confirmed and second dose in same nostrils on upcoming Pushya nakshatra)
| | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Jeevaniya Mahakashaya, Reference: Charak Samhita Sutra Sthana 4/18/1), Route: Oral, Dosage Form: Khanda /Granules, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: cowmilk), Additional Information: along with Vatashunga
Dose – 4 drops (in right or left nostrils randomly)
Dose Form – swaras (8 Vatashunga mixed with unboiled cow milk)
Time of administration – morning in empty stomach
Route of administration- nasal route
Duration- 2 sittings ( first sitting on the day after pregnancy confirmed and second dose in same nostrils on upcoming Pushya nakshatra)
|
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Married female 21-40 years age group with positive urine pregnancy test will be taken into study between 4-10 weeks of pregnancy with having history of any following conditions:
One or more spontaneous abortion
Elderly primigravida
Pregnancy after Infertility
H/O Intra Uterine fetal death
Previous preterm birth
Choriodecidual haemorrhage in present pregnancy
|
|
| ExclusionCriteria |
| Details |
Patient with severe systemic disease like cardiovascular complications, uncontrolled diabetes mellitus, hematological disorders, hyperthyroidism, Urinary tract infection etc.
Pregnancy with carcinoma, large ovarian cyst, large uterine fibroid, uterine prolapse.
Pregnancy with history of incompetent OS & congenital uterine malformations.
Pregnant female with history of previous congenital malformed child.
Sexually transmitted diseases like VDRL, HIV, HbsAg and HCV will be excluded.
Pregnancy with TORCH IgM Positive Cases.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Continuation of Pregnancy, growth & development of fetus up to 20 weeks |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in the minor ailments of pregnancy.
|
2 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 2 |
|
Date of First Enrollment (India)
|
30/11/2024 |
| 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="0"
Months="2"
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
|
Aims To evaluate the clinical efficacy of Prajasthapana Mahakashaya granules and Jeevaniya Mahakashaya granules along with Vata Shunga Nasya in Prevention of Garbhasrava (Early pregnancy loss) objectives
•PRIMARY OBJECTIVE:
To evaluate and compare clinical efficacy of Prajasthapana Mahakashaya granules with Vata Shunga Nasya and Jeevaniya Mahakashaya Granules with Vata Shunga Nasya in prevention of Garbhasrava (Early pregnancy loss)
SECONDARY OBJECTIVE:
To evaluate the effect of Prajasthapana Mahakashaya granules with Vata Shunga Nasya and Jeevaniya Mahakashaya granules with Vata Shunga Nasya on minor ailments of pregnancy. | Hypothesis | | | NULL HYPOTHESIS(H0) | There is no difference in the efficacy of Prajasthapana Mahakashaya granules with Vata Shunga Nasya and Jeevaniya Mahakashaya granules with Vata Shunga Nasya in prevention of Garbhasrava (Early Pregnancy Loss) | | ALTERNATIVE HYPOTHESIS(HA) | There is difference in the efficacy of Prajasthapana Mahakashaya granules with Vata Shunga Nasya and Jeevaniya Mahakashaya granules with Vata Shunga Nasya in prevention of Garbhasrava (Early Pregnancy Loss) | GROUPING: Group A : 40 patients will be treated by Prajasthapana Mahakashaya granules along with Vata Shunga Nasya Group B: 40 patients will be treated by Jeevaniya Mahakashaya granules with Vata Shunga Nasya DURATION OF CLINICAL TRIAL AND FOLLOW UP STUDY: Total Duration of Trial: 2 Months Follow up during treatment: At the Interval of 2 weeks up to 20 weeks of Pregnancy Follow up after treatment: 1 month
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