| CTRI Number |
CTRI/2019/03/018084 [Registered on: 14/03/2019] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment for Poly Cystic Ovarian Syndrome |
|
Scientific Title of Study
|
Pharmaceutico - Clinical Validation of Kalyanaka Kshara in the Management of P.C.O.S Induced Infertility |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anitha Suddala |
| Designation |
Assistant Professor |
| Affiliation |
Dr NRS Govt Ayurvedic College |
| Address |
Dept of Prasuthi and Stree Roga Dr NRS Govt Ayurvedic College MG Road Vijayawada Krishna Dist
dranitha2005@gmail.com
Krishna
ANDHRA PRADESH
520002
India |
| Phone |
9640868554 |
| Fax |
08662576922 |
| Email |
dranitha2005@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr PVNR Prasad |
| Designation |
Associate Professor |
| Affiliation |
Dr NTR University of Health Sciences |
| Address |
Dr PVNR Prasad
Dept of RT and BK
Room no 02
Dr NRS Govt Ayurvedic College Vijayawada
AL GOVT Ayurvedic hospital MG Road
Vijayawada 10
Dr PVNR Prasad
Dept of RT and BK
Room no 02
Dr NRS Govt Ayurvedic College Vijayawada
AL GOVT Ayurvedic hospital MG Road
Vijayawada 10
Krishna
ANDHRA PRADESH
520002
India |
| Phone |
9666671664 |
| Fax |
08662576922 |
| Email |
prasadpvnr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ANITHA SUDDALA |
| Designation |
Assistant Professor |
| Affiliation |
DR NTR UHS VIJAYAWADA AP |
| Address |
Dept of Prasuthi and Stree Roga
Dr NRS Govt Ayurvedic College MG Road Vijayawada
Krishna Dist
Dr NRS Govt Ayurvedic College
Dept of Prasuthi and Stree Roga
Dr NRS Govt Ayurvedic College MG Road Vijayawada
Krishna Dist VIJAYAWADA
Krishna
ANDHRA PRADESH
520002
India |
| Phone |
9640868554 |
| Fax |
08662576922 |
| Email |
dranitha2005@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr S Anitha |
| Address |
Dept of Prasuthi and Stree Roga Dr NRS Govt Ayurvedic College MG Road Vijayawada Krishna Dist A.P. |
| 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 |
| DR S ANITHA |
AL GOVT AYURVEDIC HOSPITAL |
PRASUTHI STREE ROGA DEPT
ROOM NO-10
Krishna
ANDHRA PRADESH |
9640868554
dranitha2005@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Dr NRS Govt Ayurvedic College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E282||Polycystic ovarian syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kalyanaka Kshara |
50 patients will be administered with Kalyanaka Kshara 250mg orally twice daily for 90 days |
| Comparator Agent |
Rajah Pravartini Vati |
A group of 50 patients will be administered with Rajah Pravartini Vati 250 mg orally twice daily with Varunadi Kashaya 20 ml for 90 Days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Married infertility patients with P.C.O.D. (Rotterdam criteria)
Irregular menses scanty menses due to Anovulatory cycle
Anovulation and Oligo amennorohoea
Elevated LH (LH:FSH ratio >3)
Clinical or biochemical evidence of Hyperandrogenism
Polycystic ovary (more than 10 follicles in a ovary or one cyst more than 10 mm)
Willing to give pre-informed consent for the study |
|
| ExclusionCriteria |
| Details |
Unmarried patients with P.C.O.D.
Age below 20 years and above 40 years
Patients associated with other gynaecological disorders
Patients suffering with any chronic diseases
Women having the history of primary amenorrhea
Patients with Tubercular endometritis
Patients with congenital anomalies in female genital tract
Patients with chronic liver disease, renal disorder, etc.
Patients with metabolic and other Endocrinal disorders like Diabetes Mellitus
Patients with Hypothyroidism |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in signs and symptoms and significant improvement of objective parameters tests to 50% baseline |
Every month
30th day, 60th day, 90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in objective parameters
Achievement of Ovulation and Fertility |
30th day, 60th day, 90th day |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
28/12/2019 |
| 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="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
S. No. Name of the Research article published Journal Volume
Page No.
1 Formulation And Evaluation of Kalyanaka Kshara: An Ayurvedic Compound Formulation. IJRAP, Vol.2023;14(2):32-37
2 Clinical efficacy of kalyanaka kshara in the management of PCOS Infertility w.s.r Anovulation IJCRT, Vol.13, issue- 3, 28-March 2025, pp k752-k760.
3 Role of Ayurveda and Yoga in the Management of Polycystic Ovarian Syndrome (PCOS) JAIMS, March 2025 Issue (Vol. 10 Issue 03)
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
A clinical trail is done to evaluate the efficacy of the Ayurvedic formulation Kalyanaka Kshara in the management of P.C.O.S Induced Infertility and to validate scientifically the observations that would significantly change the LH FSH ratio, Testosterone, Prolactin levels and also signs and symptoms of Polycystic Ovaries. Klayanaka Kshara is a unique herbal formula which has the reference in Astanga Hridaya Chikitsa Stana - a classical text. 50 patients orally 250 mg twice daily for 90 days and to compare the observation with other group in which Rajah Pravartini Vati 250 mg along with Varunadi Kashaya 20 ml administered in 50 patients for 90 days with the observation on 0 - 30 - 60 - 90 days and further follow up for secondary outcome i.e., achievement of fertility, the study would be conducted in India, to complete in 3 years and the trail time being 18 months. Primary outcome measures will be relief in signs and symptoms (subjective parameters), subsiding the P.C.O.S symptoms and achieve ovulatory cycles, fertility
|