| CTRI Number |
CTRI/2023/08/056802 [Registered on: 23/08/2023] Trial Registered Prospectively |
| Last Modified On: |
19/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Episiotomy wound healing by Tiktadyam ghrita and Ropana taila |
|
Scientific Title of Study
|
An Open Label Double Arm Randomised Controlled Clinical Study to Evaluate the Effect of Tiktadyam Ghrita in Episiotomy Wound Healing |
| 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 Nidhi |
| Designation |
Post Graduate Scholar |
| Affiliation |
Rajiv Gandhi University Of Health Science Bengaluru,Karnataka |
| Address |
Opd No.4,5,6,20,24,Ground Floor,Department of Prasuti Tantra & Streeroga Sri Dharamsthala Manjunatheshwara Institute of Ayurveda And Hospital Anchepalya Kumbalgodu Post Bengaluru Karnataka
Bangalore
KARNATAKA
560074
India |
| Phone |
8178659756 |
| Fax |
|
| Email |
nidhi@sdmayurbangalore.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pramodini JPatil |
| Designation |
Assistant Professor |
| Affiliation |
Rajiv Gandhi University Of Health Science Bengaluru,Karnataka |
| Address |
Opd No.4 Ground Floor,Department of Prasuti Tantra & Streeroga Sri Dharamsthala Manjunatheshwara Institute of Ayurveda And Hospital Anchepalya Kumbalgodu Post Bengaluru Karnataka
Bangalore
KARNATAKA
560074
India |
| Phone |
8496841492 |
| Fax |
|
| Email |
Dr.pramodinip@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nidhi |
| Designation |
PG Scholar |
| Affiliation |
Rajiv Gandhi University Of Health Science Bengaluru,Karnataka |
| Address |
Opd No.4,5,6,20,24,Ground Floor,Department of Prasuti Tantra & Streeroga Sri Dharamsthala Manjunatheshwara Institute of Ayurveda And Hospital Anchepalya Kumbalgodu Post Bengaluru Karnataka
Bangalore
KARNATAKA
560074
India |
| Phone |
8178659756 |
| Fax |
|
| Email |
nidhi@sdmayurbangalore.in |
|
|
Source of Monetary or Material Support
|
| SDM Institute of Ayurveda and Hospital Anchepalya Bengaluru |
|
|
Primary Sponsor
|
| Name |
Dr Nidhi |
| Address |
Sri Dharamsthala Manjunatheshwara Institute Of Ayurveda And Hospital Anchepalya Kumbalgodu Post Bengaluru Karnataka
|
| Type of Sponsor |
Other [Self] |
|
|
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 Nidhi |
SDM Institute of Ayurveda and Hospital |
OPD No 6 ,Department of Prasuti tantra and streeroga SDM Institute of Ayurveda Ancheplaya bengaluru
Bangalore
KARNATAKA |
8178659756
nidhi@sdmayurbangalore.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Dharamasthala Manjunatheshwara Institute of Ayurveda and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N909||Noninflammatory disorder of vulvaand perineum, unspecified. Ayurveda Condition: SADYOVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: ropana taila, Reference: susruta samhita , Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Tiktadyam ghrita, Reference: chakradutta, Route: Topical, Dosage Form: Ghrita, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Primi and multi gravida who will undergo normal vaginal delivery and had episiotomy (1st and 2nd degree) |
|
| ExclusionCriteria |
| Details |
Ventouse and forceps delivery
3rd and 4th degree perineal tear
perineal lacerations
any systemic disease
subject tested positive for HIV HBSAG VDRL |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Faster wound healing on the basis of REEDA Scale |
Baseline,7th day,15th day,21 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
15/09/2023 |
| 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)
|
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
|
Episiotomy or periotomy which can be correlated to sadyovrana is a planned incision on the perineum and posterior vaginal wall during second stage of labor. Episiotomy provides ease of child birth by widening the vaginal opening and it also protects tone of perineum and prevents undesired vaginal fissures .Episiotomy is the one of the most commonly employed procedures during women deliveries in hospital of India. The rate of episiotomy was found to be 93.3% in primipara and 30.2% in multi para women. After episiotomy the concern is wound healing. Acharyas have mentioned lepana i.e. tropical application of taila and ghrita in chikitsa of vrana.Hence Tiktadyam ghrita and Ropana taila which is mentioned in vrana chikitsa having vrana shodhana and vrana ropana properties are selected for the current study |