| CTRI Number |
CTRI/2025/07/090732 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
10/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to see how effective two herbal oil treatments are (Kumari Siddha Taila and Shatpushpa Siddha Taila) when used as enemas for helping women with PCOS who arent ovulating. |
|
Scientific Title of Study
|
A RANDOMISED CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY OF KUMARI SIDDHA TAILA MATRABASTI AND SHATPUSHPA SIDDHA TAILA MATRABASTI IN ANOVULATORY CYCLE IN ANOVULATORY CYCLE IN PCOS |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSampada Anil Shinde |
| Designation |
PG Scholar |
| Affiliation |
Tilak ayurvedic mahavidyalaya rasta peth pune |
| Address |
Tilak Ayurved Mahavidyalaya Department of stress Roga and Prasuti-Tantra 1st floor 583/2 Rasta peth pune MAHARASHTRA 411011
India
Pune
MAHARASHTRA
411011
India |
| Phone |
9834620757 |
| Fax |
|
| Email |
Sampadashinde2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRucha Ganu |
| Designation |
Associate professor |
| Affiliation |
Tilak ayurvedic mahavidyalaya rasta peth pune |
| Address |
Department of stress Roga and Prasuti-Tantra 1st floor 583/2 Rasta peth pune MAHARASHTRA 411011
India
Pune
MAHARASHTRA
411011
India |
| Phone |
9822376936 |
| Fax |
|
| Email |
ganu.rucha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrRucha Ganu |
| Designation |
Associate professor |
| Affiliation |
Tilak ayurvedic mahavidyalaya rasta peth pune |
| Address |
Department of stress Roga and Prasuti-Tantra 1st floor 583/2 Rasta peth pune MAHARASHTRA 411011
India
Pune
MAHARASHTRA
411011
India |
| Phone |
9822376936 |
| Fax |
|
| Email |
ganu.rucha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth Tarachand Ramanath Charitable Ayurvedic Hospital pune maharashtra 411011 |
|
|
Primary Sponsor
|
| Name |
Tilak ayurvedic mahavidyalaya rasta peth Pune |
| Address |
Tilak Ayurved Mahavidyalaya Department of stress Roga and Prasuti-Tantra 1st floor 583/2 Rasta peth pune MAHARASHTRA 411011
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 |
| DrSampada Anil Shinde |
Seth Tarachand Ramanath Charitable Ayurvedic Hospital Pune |
Tilak Ayurved Mahavidyalaya Department of stress Roga and Prasuti-Tantra OPD 11
Ground floor 583/2 Rasta peth pune MAHARASHTRA 411011
India
Pune
MAHARASHTRA |
9834620757
Sampadashinde2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Tilak Ayurveda Mahavidyalaya |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N915||Oligomenorrhea, unspecified. Ayurveda Condition: ARTAVAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shatpushpa siddha taila, Reference: Charak sutra 4/13, Route: Rectal, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Bhaishajya Kal: Sabhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kumari siddha taila , Reference: Aayurvedvidnyan , Route: Rectal, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Bhaishajya Kal: Sabhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Age group 18-35 years.
Diagnosis Ultrasound Polycystic ovarian morphology.
Diagnosed cases of PCOS with any of the following symptoms
Ovulatory dysfunction refers to Oligomenorrhea or amenorrhea.
Anovulatory Cycles
Irregular Menses/ Scanty Menses.
Hirsutism
Obesity
Acanthosis Nigricans |
|
| ExclusionCriteria |
| Details |
Patients having history of
Systemic diseases like Diebetes mellitus, Hypertension, etc.
Irregular menses due to anatomical defect in reproductive system such as Hypoplastic Uterus,
Aplastic Uterus, Streak Ovaries, Hypogonadism.
Menorrhagia in PCOS. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study will analyze the clinical signs and symptoms to determine the effectiveness of each treatment. |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No any |
No ANY |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/08/2025 |
| 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 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
|
The study will be intervened by the treatment of Kumari siddha tail matra basti and Shatpushpa siddha taila matra basti to group A and group B respectively. The efficacy of the therapy will be assessed on the basis of subjective and objective criteria for statistical analysis. Scoring will be designed according to the severity of symptoms. The subjective and objective gradation of symptoms will be done as follows and the intensity of each symptom will be calculated before treatment, after treatment and after follow up. The effect of treatment result will be assessed in regards to clinical signs and symptoms on the basis of grading and scoring system. The signs and symptoms will be assessed by adopting the suitable scoring method. |