| CTRI Number |
CTRI/2023/08/055952 [Registered on: 01/08/2023] Trial Registered Prospectively |
| Last Modified On: |
26/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate effect of Tiladi Kwatha Orally & Shatpushpa Siddha Taila Nasya in the treatment of Pushpaghni (PCOS) |
|
Scientific Title of Study
|
"CLINICAL STUDY OF TILADI KWATHA ORALLY AND SHATPUSHPA SIDDHA TAILA NASYA IN THE MANAGEMENT OF PUSHPAGHNI†(PCOS) |
| Trial Acronym |
CSTKSTN |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanoor Bano |
| Designation |
P.G. Scholar |
| Affiliation |
Post Graduate Institute of Ayurveda, DSRRAU Jodhpur |
| Address |
P.G Department of Prasuti Tantra evam Stri Roga, Post Graduate Institute of Ayurved, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Nagaur Road, Karwad, Jodhpur,
RAJASTHAN 342037
India
P.G Department of Prasuti Tantra evam Stri Roga, Post Graduate Institute of Ayurved, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Nagaur Road, Karwad, Jodhpur,
RAJASTHAN 342037
India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9672256870 |
| Fax |
|
| Email |
sanurbano721@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi Sharma |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute of Ayurveda, DSRRAU Jodhpur |
| Address |
P.G Department of Prasuti Tantra evam Stri Roga, Post Graduate Institute of Ayurved, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Nagaur Road, Karwad, Jodhpur,
RAJASTHAN 342037
India
P.G Department of Prasuti Tantra evam Stri Roga, Post Graduate Institute of Ayurved, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Nagaur Road, Karwad, Jodhpur,
RAJASTHAN 342037
India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9166607559 |
| Fax |
|
| Email |
vd_rashmi11@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanoor Bano |
| Designation |
P.G. Scholar |
| Affiliation |
Post Graduate Institute of Ayurveda, DSRRAU Jodhpur |
| Address |
P.G Department of Prasuti Tantra evam Stri Roga, Post Graduate Institute of Ayurved, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Nagaur Road, Karwad, Jodhpur,
RAJASTHAN 342037
India
P.G Department of Prasuti Tantra evam Stri Roga, Post Graduate Institute of Ayurved, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Nagaur Road, Karwad, Jodhpur,
RAJASTHAN 342037
India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9672256870 |
| Fax |
|
| Email |
sanurbano721@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurved, Jodhpur Rajasthan |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurved, Jodhpur Rajasthan |
| Address |
P.G Department of Prasuti Tantra evam Stri Roga, Post Graduate Institute of Ayurved, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Nagaur Road, Karwad, Jodhpur,
RAJASTHAN 342037
India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sanoor Bano |
P.G Department of Prasuti Tantra evam Stri Roga, Post Graduate Institute of Ayurved, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Nagaur Road, Karwad, Jodhpur,
RAJASTHAN 342037
India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanoor Bano |
Post Graduate Institute of Ayurved Jodhpur |
P.G Department of Prasuti Tantra evam Stri Roga, Post Graduate Institute of Ayurved, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Nagaur Road, Karwad, Jodhpur,
RAJASTHAN 342037
India
Jodhpur
RAJASTHAN |
9672256870
sanurbano721@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Post graduate institute of Ayurveda Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E282||Polycystic ovarian syndrome. Ayurveda Condition: ARTAVADOSHAH/ARTAVADUSHTIH/RAJODOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam, नसà¥à¤¯à¤®à¥ | (Procedure Reference: Sharangdhar Samhita Madhyam khanda, Procedure details: Shatpushpa Siddha Tail will be made by Reference of “Sneha Kalpana†in Sharangdhar Samhita Madhyam khanda. 1 part of Kalka darvya and 4 parts of tail and 16 parts of Kwatha will be mixed and it will be heated till only Sneha (oil) remains. )
(1) Medicine Name: Shatpushpa Siddha Taila, Reference: का. स/. शतपà¥à¤·à¥à¤ªà¤¾ शतावरी कलà¥à¤ª/, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: od, Duration: 42 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Tiladi Kwatha, Reference: ग० नि०ष०ख०1/59, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 42 Days, anupAna/sahapAna: Yes(details: -Koshan Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Patients diagnosed cases of PCOS by the Rotterdam criteria.
2.Age: Patients aged between 16-40 years.
3. The patients who are fit for the Nasya procedure were only considered for the study.
4. Patients willing for Informed consent.
|
|
| ExclusionCriteria |
| Details |
•Patients having any other disease causing oligomenorrhea and anovulation excluding PCOD on the above criteria.
•Patients using oral contraceptive pills.
•Pregnant and lactating women.
•Patients suffering from thyroid abnormalities, Hyperprolactinemia, adrenal hyperplasia etc.
•Patients with any organic reproductive system abnormalities like hydrosalpinx, endometriosis, fibroid uterus, carcinoma of reproductive organ and sexually transmitted disease (STDs), Human Immunodeficiency Virus (HIV), Hepatitis B Surface Antigen (HBsAg).
•Systemic disorders like-uncontrolled diabetes mellitus, chronic liver disease, renal disorder, Uncontrolled hypertension, Diagnosed case of any type of malignancy.
•Patients who are contraindicated for Nasya like, Nasal polyp etc.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Assessment for Menstrual abnormality (Oligomenorrhea)
2.Assessment for Hypomenorrhea
3.Assessment for Menorrhagia
4.Pain associated with Menstruation
5.Assessment of Acne (according to acne grading)
6.Assessment of Hirsutism (on the basis of site)
|
for 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Percentage improvement in reduction of ovarian size, volume, stromal pattern
• Percentage improvement in biochemical values.
•Percentage improvement in hormonal assays.
•Weight reduction as assessed by reduction in Body weight, BMI |
60 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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/08/2023 |
| 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="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 is single group clinical study, open label to evaluate the effect of nasya with shatpushpa taila and tiladi kwatha in the management of Pushpughni (PCOS). The primary outcome of this treatment to reduce menstrual abnormality (Oligomenorrhea) , hypomenorrhea, Menorrhagia, Pain associated with Menstruation ,Assessment of Acne (according to acne grading) , Hirsutism (on the basis of site). |