| CTRI Number |
CTRI/2026/02/103491 [Registered on: 10/02/2026] Trial Registered Prospectively |
| Last Modified On: |
09/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Surgical/Anesthesia
Other (Specify) [Suture material] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
“Which Thread Helps the Cut Given During Childbirth Heal Better – Banana Stem Fibre or Regular Surgical Thread?” |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY ON THE EFFICACY OF PANCHAVALKALA KASHAYA SADHITA KADALI KANDA SUTRA WITH CHROMIC CATGUT IN THE MANAGEMENT OF 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 Pratibha Channayyanavar |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Department of Stree Roga Evam Prasuti Tantra Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla Hassan Karnataka India
Hassan
KARNATAKA
573201
India |
| Phone |
07406343200 |
| Fax |
|
| Email |
pratibhachannayyanavar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gayathri Bhat N V |
| Designation |
Professor and Head of the Department |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Department of Stree Roga Evam Prasuti Tantra Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla Hassan Karnataka India
Hassan
KARNATAKA
573201
India |
| Phone |
09844437917 |
| Fax |
|
| Email |
gaya3hassan@googlemail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayathri Bhat N V |
| Designation |
Professor and Head of the Department |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Department of Stree Roga Evam Prasuti Tantra Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla Hassan Karnataka India
Hassan
KARNATAKA
573201
India |
| Phone |
09844437917 |
| Fax |
|
| Email |
gaya3hassan@googlemail.com |
|
|
Source of Monetary or Material Support
|
| SDM College of Ayurveda and Hospital, Thanniruhalla, Hassan 573201
|
|
|
Primary Sponsor
|
| Name |
SDM college of ayurveda and Hospital |
| Address |
SDM college of ayurveda and Hospital Thanniruhalla Hassan 573201
Karnataka India |
| Type of Sponsor |
Private 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 Pratibha Channayyanavar |
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA & HOSPITAL |
IPD of department of Prasooti tantra and Stree roga at Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla Hassan 573201 Hassan KARNATAKA
Hassan
KARNATAKA |
07406343200
pratibhachannayyanavar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Of Ethics Committee Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital Hassan |
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: VRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | sIvana-karma, सीवन-कर्म | (Procedure Reference: Sushrutha Sutra Sthana 25/21-22, Procedure details: The subject will be made to lie in dorsal recumbent position. Perineal area & wound will be cleaned with sukhoshna jala. The area will be gently dried with a sterile gauze piece. Episiotomy wound will be sutured using Panchavalkala Kashaya Shadhita Kadali Kanda Sutra in three layers.Proper hemostasis will be ensured, & suture approximation will be confirmed.The wound site will be covered with a sterile pad. Standard post operative episiotomy wound care will be followed in both the groups. Subjects will be advised to:
Maintain strict local hygiene & perineal care.
Avoid squatting position until complete healing.
Refrain from strenuous physical activity & lifting heavy weights during the
observation period.
Attend scheduled follow-up visits on Day 3, Day 7, & Day 14 for clinical assessment.
Report any signs of infection, excessive pain, or discharge immediately.
)
| | 2 | Comparator Arm (Non Ayurveda) | | - | Catgut suture | The subject will be made to lie in dorsal recumbent position. Perineal area & wound will be cleaned with sukhoshna jala. The area will be gently dried with a sterile gauze piece. Episiotomy wound will be sutured using Catgut suture in three layers. Proper hemostasis will be ensured, & suture approximation will be confirmed. The wound site will be covered with a sterile pad. Standard post operative episiotomy wound care will be followed in both the groups. Subjects will be advised to: Maintain strict local hygiene & perineal care. Avoid squatting position until complete healing. Refrain from strenuous physical activity & lifting heavy weights during the observation period. Attend scheduled follow-up visits on Day 3, Day 7, & Day 14 for clinical assessment. Report any signs of infection, excessive pain, or discharge immediately. ) |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1Age group between 18 to 35 years irrespective of parity
2Willing to participate and provide written informed consent
|
|
| ExclusionCriteria |
| Details |
1Presence of pre-existing perineal infections or systemic infections
2Patients with uncontrolled diabetes mellitus anemia Hb less than 8 gram per dl or other chronic illnesses affecting wound healing
3Known allergy or hypersensitivity to suture materials or study drugs
4Women with perineal tears other than episiotomy
5Previous history of episiotomy complications
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcome
Clinical efficacy of wound healing as measured by
Reduction in REEDA Score between Day 1 and Day 14
|
14 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Outcomes
Pain assessment using the Visual Analogue Scale VAS at each follow up
Time taken for wound approximation and epithelialization
|
14 Days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/03/2026 |
| 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="2"
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
|
Episiotomy is commonly performed to prevent severe perineal tears during childbirth especially in primiparous women Chromic catgut though widely used for perineal repair is associated with tissue reactivity variable absorption delayed wound healing discomfort and ethical concerns due to its animal origin. Ayurvedic concepts of Yoni Kshata correlate with perineal injury and classical texts support the use of plant based fibers for wound management Kadali Kanda Sutra derived from banana pseudostem and processed with Panchavalkala Kashaya offers wound healing hemostatic cooling biodegradable ethical and sustainable advantages However scientific validation is limited necessitating a comparative clinical study to evaluate its efficacy and safety in episiotomy wound healing |