| CTRI Number |
CTRI/2025/12/098988 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
11/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy of shatapushpa taila matra basti with oral administraion of yograja guggulu and kumaryasava in polycystic ovarian syndrome |
|
Scientific Title of Study
|
Efficacy of shatapushpa taila matra basti with oral administration of yograja guggulu and kumaryasava in the management of polycystic ovarian syndrome A single arm clinical study |
| 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 vinita dhakad |
| Designation |
PG scholar |
| Affiliation |
All india institute of ayurveda |
| Address |
405 Seminar hall department of Stree roga and prasuti tantra all india institute of ayurveda Gautampuri Sarita vihar New Delhi 110076
South
DELHI
110076
India |
| Phone |
9772128721 |
| Fax |
|
| Email |
dhakadvinita7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujata kadam |
| Designation |
Professor |
| Affiliation |
All india institute of ayurveda |
| Address |
4th Floor 405 Seminar hall department of Stree roga and prasuti tantra All india institute of ayurveda Gautampuri Sarita vihar New Delhi 110076
South
DELHI
110076
India |
| Phone |
9890305370 |
| Fax |
|
| Email |
sujatadkadam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujata kadam |
| Designation |
Professor |
| Affiliation |
All india institute of ayurveda |
| Address |
4th Floor 405 Seminar hall Department of Stree roga and prasuti tantra all india institute of ayurveda Gautampuri Sarita vihar New Delhi 110076
South
DELHI
110076
India |
| Phone |
9890305370 |
| Fax |
|
| Email |
sujatadkadam@gmail.com |
|
|
Source of Monetary or Material Support
|
| All india institute of ayurveda gautampuri sarita vihar new delhi 110076 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
Gautampuri Sarita Vihar New Delhi 110076 |
| Type of Sponsor |
Government 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 Vinita Dhakad |
All India Institute Of Ayurveda |
Gyne opd no.203 All India Institute Of Ayurveda Gautampuri Sarita Vihar New Delhi 110076
South
DELHI |
9772128721
dhakadvinita7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIA INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E282||Polycystic ovarian syndrome. Ayurveda Condition: GRANTHIBUTA-ARTAVADUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | mAtrAbastiH, मात्राबस्तिः | (Procedure Reference: charak samhita, Procedure details: preparation of the medicine
sarvanga abhyanga and sarvanga swedana will be
done
patient lied down to left lateral position
check the temperature(39 degree celcius) of the medicine and load it in
60ml syringe
lubricate the anal verge and rubber catheter with
oil.
introduce the rubber catheter about 4.5 cm into the Anal
canal
gently push the medication with uniform pressure
after introducing medication take out the basti nozzle
gently tap the gluteal region
patient is asked to remain in same position for 15 minutes )
(1) Medicine Name: Yograja, Reference: शाङ्र्धर संथहता मर्ध्म खण्डा 7/५६ -६२ ६५,६६, Route: Oral, Dosage Form: Guggulu, Dose: 1(g), Frequency: bd, Duration: 3 Months(2) Medicine Name: kumaryasava, Reference: शागषधर म्यम खण्ड १०/१८ २७ १/२, Route: Oral, Dosage Form: Asava, Dose: 20(ml), Frequency: bd, Duration: 90 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1 Female patient aged 18 to 40 years married or
unmarried diagnosed with PCOS by Rotterdam
Criteria must meet at least 2 of 3
Anovulation oligo or amenorrhea
Hyperandrogenism clinical or biochemical
Polycystic ovaries on ultrasound
A polycystic ovary is defined as an ovary containing 12 or more follicles or 25 or more follicles using new ultrasound technology measuring 2 to 9 mm in diameter or an ovary that has a volume of greater than 10 mL on ultrasonography
2 Patient must be willing to provide voluntary
informed consent
3 NIH Criteria 1990
To include both of the following
Oligo ovulation
Hyperandrogenism
4 AE PCOS 2009
1 Hyperandrogenism hirsutism and or
hyperandrogenemia
2 Ovarian dysfunction Oligo-anovulation and or
polycystic ovaries
3 Exclusion of other androgen excess or related disorders |
|
| ExclusionCriteria |
| Details |
a Primary amenorrhea
b Pregnancy
c Pelvic systemic conditions causing
oligo anovulation or other gynecological disorders endometriosis hydrosalpinx uterine fibroids
d Endocrine disorders unrelated to PCOS thyroid disease hyperprolactinemia congenital adrenal hyperplasia pituitary adenomas
e Organic reproductive tract lesions
tuberculosis malignancy carcinoma
f Chronic systemic disease hypertension diabetes liver or renal disease Cushing’s syndrome
cardiovascular disease
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in ovarian volume in USG pelvis findings |
Reduction in ovarian volume in USG pelvis findings in 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Regulation of menstrual cycle hormonal profile decreases acne BMI hirsutism |
Regulation of menstrual cycle in 3months |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
08/03/2026 |
| 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 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
|
RESEARCH QUESTION-
What is the effect of Shatapushpa Taila Matra Basti 60ml for 7 days for three consecutive cycles
after menses with oral administration of Yograja Guggulu 500mg 2 BD and Kumaryasava 20ml
BD for 90 days in the management of PCOS? HYPOTHESIS-
Administration of Shatapushpa Taila Matra Basti along with oral Yograja Guggulu and
Kumaryasava is effective in improving clinical sign symptoms and hormonal profile in patients
with Polycystic Ovarian Syndrome (PCOS).
NULL HYPOTHESIS-
Administration of Shatapushpa Taila Matra Basti 60ml for 7 days for three consecutive cycles
after menses with oral administration of Yograja Guggulu 500mg 2BD and Kumaryasava 20ml
BD for 90days is not effective in improving clinical sign symtoms and hormonal profile in
PCOS.
ALTERNATE HYPOTHESIS-
Administration of Shatapushpa Taila Matra Basti 60ml for 7 days for three consecutive cycles
after menses with oral administration of Yograj Guggulu 500mg 2BD and Kumaryasava 20ml
BD for 90days is effective in improving clinical sign symtoms and hormonal profile in PCOS.
NEED OF STUDY-
PCOS is a heterogeneous endocrine disorder that affects one in 15 women worldwide. It is the
most frequent cause of hyperandrogenism & anovulation which have substantial psychological,
social & economic consequences. Lifestyle changes & lack of awareness are considered to be the
major factor leading to this phenomenon.
In modern system of medicine oral contraceptives, ovulation induction agents, progestin,
antiandrogens and surgical interventions remain standard therapies having a number of side
effects like Depression, Weight gain, Hot flushes, Hepatotoxicity and Nephrotoxicity etc. If
PCOS is not treated timely it may lead to cardiovascular disease, endometrial cancer and ovarian
cancer. it may lead to infertility, Risk of miscarriages and a high risk of developing diabetes, high
blood pressure and other health complications. Therefore there is increased demand to address
the problem from view of Ayurvedic medicine which gives better relief, it becomes important in
field of Ayurveda develop a safe, cost effective, conservative, non invasive treatment protocol
for PCOS.
In Ayurveda (PCOS) can be classified as Granthibhoot Artava Dushti due to Vatakaphaja dosha.
To restore normal menstruation Vatakaphanashak chikitsa is equally important. The treatment
should aim at the correction of obesity and clear the Aavarana by using Vata Kapha Shamaka
drugs which certainly help in the proper ovulation and menstruation.
OBJECTIVES:
Primary Objective:
• To evaluate the efficacy of Shatpushpa Taila Matra Basti with oral administration of Yograja
Guggulu and Kumaryasava in reduction of ovarian volume. Secondary Objectives:
• To observe changes(interval, duration, menstural blood flow, pain during mensturation) in
menstrual cycle and improvement in hormonal profile.
• To evaluate changes in the following
• Acne
• BMI
• Hirsutism(Ferriman-Gallwey scale)
|