| CTRI Number |
CTRI/2022/07/044131 [Registered on: 19/07/2022] Trial Registered Prospectively |
| Last Modified On: |
14/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of Kadambmasha Anuvasana Basti and Badrodak Asthapna Basti in normal delivery |
|
Scientific Title of Study
|
A Clinical study to evaluate the Efficacy of Kadambmasha Anuvasana Basti and Badrodak Asthapna Basti in Sukh and Nirupdrava Prasava |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Soni Kapil |
| Designation |
Reader, Department of Prasuti Tantra evum Stree Roga |
| Affiliation |
RGGPG Ayurvedic College and Hospital, Paprola |
| Address |
Room no. 203, Department of Prasuti Tantra evum Stree Roga, RGGPG Ayurvedic College and Hospital, Paprola, Distt. Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418499799 |
| Fax |
|
| Email |
skbhardwaj73@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Soni Kapil |
| Designation |
Reader, Department of Prasuti Tantra evum Stree Roga |
| Affiliation |
RGGPG Ayurvedic College and Hospital, Paprola |
| Address |
Room no. 203, Department of Prasuti Tantra evum Stree Roga, RGGPG Ayurvedic College and Hospital, Paprola, Distt. Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418499799 |
| Fax |
|
| Email |
skbhardwaj73@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nisha Kumari |
| Designation |
PG Scholar |
| Affiliation |
RGGPG Ayurvedic College and Hospital, Paprola |
| Address |
Room no. 804, Department of Prasuti Tantra evum Street Roga, RGGPG Ayurvedic College and Hospital, Paprola, Distt. Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8265031734 |
| Fax |
|
| Email |
nisha27bhatia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Pharmacy, RGGPG Ayurvedic College and Hospital |
| ISM Jogindernagar |
|
|
Primary Sponsor
|
| Name |
Principal RGGPG Ayurvedic College and Hospital Paprola |
| Address |
Principal Room, Admin Block, RGGPG Ayurvedic College and Hospital, Paprola, Distt. Kangra HP 176115 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| HOD Department of Prasuti Tantra Evum Stree Roga |
RGGPG Ayurvedic College and Hospital, Paprola, Distt. Kangra H. P. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Soni Kapil |
RGGPG Ayurvedic College and Hospital, Paprola |
OPD and IPD of Department of Prasuti Tantra evum Stree Roga, RGGPG Ayurvedic College and Hospital, Paprola
Kangra
HIMACHAL PRADESH |
9418499799
skbhardwaj73@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Human), RGGPG Ayurvedic College and Hospital, Paprola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O80||Encounter for full-term uncomplicated delivery. Ayurveda Condition: GARBAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kadambmasha Taila, Reference: Bhel Samhita Sharir Sthana 8/7, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 3 Weeks, anupAna/sahapAna: No, Additional Information: Kadambmasha Taila 60ml per rectal twice weekly for 3 weeks and at the onset of labour after Badrodak Asthapna Basti(2) Medicine Name: Badrodak Kwath, Reference: Sushruta Samhita Sharir Sthana 10/4, Route: Rectal, Dosage Form: Kwatha/ Kashaya, Dose: 960(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: Badrodak Kwath 960ml per rectal at the onset of labour | | 2 | Comparator Arm (Non Ayurveda) | | - | Standard ANC Protocol | Standard ANC Protocol |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Cases having haematological/routine ANC investigations within normal limits.
2. Patients having adequate pelvis, borderline pelvis and cephalic presentation. |
|
| ExclusionCriteria |
| Details |
1. Cephalopelvic disproportion.
2. Patient not willing for trial.
3. Patients having mal presentation.
4. Antepartum haemorrhage.
5. Patients having Hb less than 9gm%.
6. Patients having any gynaecological conditions or systemic disease.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Onset of spontaneous labour and normal progress of labour.
2. Delivery of fetus with minimal aids. |
32 weeks to onset of Labour (5-7 weeks).
1. Patient will be observed after intervention whether the pregnant woman has sukha and nirupdrava prasava or not and
2. whether onset of labour is spontaneous or induced |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Uneventful complition of labour without interfering maternal and fetal health |
Mother and Infant will be observed regularly for 14 days after delivery for any complication |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
14/08/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Research Report will be soon published after the completion of trial. 100 patients fulfilling the inclusion and exclusion criteria will be randomly selected from the OPD and IPD of Department of Prasuti Tantra evum Stree Roga, RGGPG Ayurvedic College and Hospital, Paprola. Patients will be divided randomly into 2 groups; Group I and Group II each with 50 patients. Group I will be given Kadambmasa Anuvasana Basti (Matra Basti) twice weekly for consecutive 3 weeks and Badrodak Asthapna Basti followed by Anuvasna Basti at the onset of labour while Group II includes the pregnant women under observation by following standard protocol used for ANC and normal labour (non-interventional). Result will be assessed on the basis of subjective and objective assessment criteria. |