| CTRI Number |
CTRI/2026/02/103089 [Registered on: 05/02/2026] Trial Registered Prospectively |
| Last Modified On: |
05/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study To Evaluate The Efficacy of Nirgundyadi Taila Application in Management of Sutika Prushtashool |
|
Scientific Title of Study
|
A single arm open label clinical study To Evaluate The Efficacy of Nirgundyadi Taila Application in Management of Sutika Prushtshool |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSakshi Shivraj Swami |
| Designation |
PG scholar |
| Affiliation |
Ashtang Ayurved Mahavidyalaya Sadashiv peth Pune |
| Address |
868, Streeroga Prasutitantra department Ashtang Ayurved Mahavidyalaya Sadashiv peth Pune
Pune
MAHARASHTRA
411030
India |
| Phone |
9579558478 |
| Fax |
|
| Email |
sakshiswami139@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemalata Jalgaonkar |
| Designation |
HOD |
| Affiliation |
Ashtang Ayurved Mahavidyalaya Sadashiv peth Pune |
| Address |
868, Streeroga Prasutitantra department Ashtang Ayurved Mahavidyalaya Sadashiv peth Pune
Pune
MAHARASHTRA
411030
India |
| Phone |
9881166344 |
| Fax |
|
| Email |
hrj9371@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSakshi Shivraj Swami |
| Designation |
PG Scholar |
| Affiliation |
Ashtang Ayurved Mahavidyalaya Sadashiv peth Pune |
| Address |
868, Streeroga Prasutitantra department Ashtang Ayurved Mahavidyalaya Sadashiv peth Pune
Pune
MAHARASHTRA
411030
India |
| Phone |
9579558478 |
| Fax |
|
| Email |
sakshiswami139@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ashtang Ayurved Mahavidyalaya Sadashiv peth Pune Maharashtra 411030 |
|
|
Primary Sponsor
|
| Name |
DrSakshi Shivraj Swami |
| Address |
868, Streeroga Prasutitantra department Ashtang Ayurveda Mahavidyalaya Sadashiv peth Pune 411030 |
| 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 |
| DrSakshi Shivraj Swami |
Ashtang Ayurved Mahavidyalaya Sadashiv peth Pune |
868, Streeroga Prasutitantra department Ashtang Ayurved Mahavidyalaya Sadashiv peth Pune
Pune
MAHARASHTRA |
9579558478
sakshiswami139@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O909||Complication of the puerperium, unspecified. Ayurveda Condition: SUTIKAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | aBya~ggaH EkA~gga | (Procedure Reference: Yogratnakar , Procedure details: Local application of Nirgundyadi Taila helps to reduce sthanic rukshatva, to reverse the direction of vitiated vat and breaks the sthansanshraya. Ultimately relieves the pain.)
(1) Medicine Name: Nirgundyadi Taila , Reference: Yogratnakar, Route: Topical, Dosage Form: Taila, Dose: 150(ml), Frequency: bd, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Patient delivered by normally and by cesarean section
|
|
| ExclusionCriteria |
| Details |
1.Complication like PPH, Puerperal sepsis
2.Blood Coagulopathy
3.Patient having Immunocomprised disease and spine disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the efficacy of Local Application of Nirgundyadi Taila in Sutika Prushtashool |
To determine the efficacy of Local Application of Nirgundyadi Taila in Sutika Prushtashool for 7days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the efficacy of Nirgundyadi Taila Application in management of Sutika Prushtashool |
To determine the efficacy of Nirgundyadi Taila Application in management of Sutika Prushtashool |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/02/2026 |
| 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="1"
Months="6"
Days="18" |
|
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
|
The current study aimed as assessment of efficacy of Nirgundyadi Taila application in management of Sutika Prushtashool. Total 60 diagnosed patients will be applied Nirgundyadi Taila for 7 days after cesarean and normal vaginal delivery. Assessment will be done by observing patients response. |