| CTRI Number |
CTRI/2024/07/070948 [Registered on: 22/07/2024] Trial Registered Prospectively |
| Last Modified On: |
12/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Clinical study to compare the effect of Kakubhadi Malahara on the suture site following normal vaginal delivery |
|
Scientific Title of Study
|
Comparative Clinical Study on the effectiveness of Kakubhadi Malahara on Episiotomy Wound |
| 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 Nidhisha Singla |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara college of ayurveda and hospital, Hassan |
| Address |
Department of Prasuti tantra evum Stree roga, Sri Dharmasthala Manjunatheshwara college of ayurveda and hospital, B M road, Thanniruhalla, Hassan, Karnataka
Hassan
KARNATAKA
573201
India |
| Phone |
7404234481 |
| Fax |
|
| Email |
pg22147@sdmcahhassan.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prathima |
| Designation |
Associate Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara college of ayurveda and hospital, Hassan |
| Address |
Department of Prasuti tantra evum Stree roga, Sri Dharmasthala Manjunatheshwara college of ayurveda and hospital, B M road, Thanniruhalla, Hassan, Karnataka
Hassan
KARNATAKA
573201
India |
| Phone |
9611990497 |
| Fax |
|
| Email |
drprathima@sdmcahhassan.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nidhisha Singla |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara college of ayurveda and hospital, Hassan |
| Address |
Department of Prasuti tantra evum Stree roga, Sri Dharmasthala Manjunatheshwara college of ayurveda and hospital, B M road, Thanniruhalla, Hassan, Karnataka
Hassan
KARNATAKA
573201
India |
| Phone |
7404234481 |
| Fax |
|
| Email |
pg22147@sdmcahhassan.org |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara college of ayurveda and hospital, B M road, Thanniruhalla, Hassan, Karnataka-573201; Phone number-08172256460; E-mail-sdmcah@gmail.com |
|
|
Primary Sponsor
|
| Name |
SDM Teaching Pharmacy |
| Address |
Sri Dharmasthala Manjunatheshwara college of ayurveda and hospital, B M road, Thanniruhalla, Hassan, Karnataka-573201; Phone number-7404234481; E-Mail- pg22147@sdmcahhassan.org |
| 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 Nidhisha Singla |
SDM college of ayurveda and hospital |
OPD-20, IPD of Department of Prasuti tantra evum Stree Roga
Sri Dharmasthala Manjunatheshwara college of ayurveda and hospital, B M road, Thanniruhalla, Hassan, Karnataka-573201
Hassan
KARNATAKA |
7404234481
pg22147@sdmcahhassan.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sri Dharmasthala Manjunatheshwara college of ayurveda and hospital, B M road, Thanniruhalla, Hassan, Karnataka-573201, India |
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: SADYOVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: KAKUBHADI MALAHARA, Reference: BHAVA PRAKASHA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Povidone Ointment | Dose-5 Grams, Duration- 15 Days, Frequency-BD |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. All primi and multi gravida with Episiotomy wound.
2. Ready to sign the informed and written bilingual consent form.
3. Fulfilling the diagnostic criteria. |
|
| ExclusionCriteria |
| Details |
1. Diagnosed case of severe anaemia.
2. Tested positive with HIV, VDRL, HBsAG.
3. Diagnosed case of Diabetes mellitus.
4. Diagnosed with Skin disorder.
5. History of impaired wound healing and repair.
6. 3rd and 4th degree laceration of the perineum.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Healing of Episiotomy wound. |
Interim Assessment- Day 3
1st Follow up- Day 15
2nd Follow up-Day 30
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction of pain. |
Interim Assessment- Day 3
1st Follow up- Day15
2nd Follow up- Day 30
|
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study is open label double arm clinical trail to evaluate the possible effect of Kakubhadi Malahara on the wound activity of Episiotomy wound and to compare its possible effect with Povidone ointment.
This study will be conducted at In-Patient Department of Prasuti Tantra Evum Stree Roga at Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital, Hassan, Karnataka.
Method- Sample will divided into two group.
Group A (Trial Intervention)- Kakubhadi Malahara Group B (Control Intervention)- Povidone ointment Frequency- Twice a day Duration- 7 days Dose- Sufficient quantity
Assessment of result will be done before and after the treatment on the basis of following subjective and objective parameters.
Subjective Parameters- Perineal pain, tenderness, difficulty in walking, difficulty in sitting, difficulty in defecation.
Objective Parameters- Perineal healing, the standard REEDA SCALE will be used. R- Redness O- Oedema E- Ecchymosis, D- Discharge A- Approximation of the wound edges. |