| CTRI Number |
CTRI/2019/04/018762 [Registered on: 24/04/2019] Trial Registered Prospectively |
| Last Modified On: |
03/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Randomized Comparative Clinical Study of Lodhra Churna with Krishna
Tila Kwatha and Shatapushpa Taila Matra Basti in the Management of PCOS |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Study of Lodhra Churna with Krishna
Tila Kwatha and Shatapushpa Taila Matra Basti in the Management of
Artavakshaya w. s. r. to Polycystic Ovarian Syndrome |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Usha Kumari |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
P.G. Department of Prasuti tantra and Stri roga
National Institute of Ayurveda
Jaipur
Rajasthan
Pincode- 302002
India
D/o Shishram Saini Vill- Kishanpura Post-Sultana Dist- Jhunjhunu
Rajasthan
Pincode-333028
Jhunjhunun
RAJASTHAN
302002
India |
| Phone |
9785377793 |
| Fax |
|
| Email |
dr.ushakumari14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Usha Kumari |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
P.G. Department of Prasuti tantra and Stri roga,
National Institute of Ayurveda,
Jaipur
Rajasthan
Pincode- 302002
India
D/o Shishram Saini, Vill- Kishanpura, Post-Sultana, Dist- Jhunjhunu,
Rajasthan
Pincode-333028
Jhunjhunun
RAJASTHAN
302002
India |
| Phone |
9785377793 |
| Fax |
|
| Email |
dr.ushakumari14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Usha Kumari |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
P.G. Department of Prasuti tantra and Stri roga,
National Institute of Ayurveda,
Jaipur
Rajasthan
Pincode- 302002
India
D/o Shishram Saini, Vill- Kishanpura, Post-Sultana, Dist- Jhunjhunu,
Rajasthan
Pincode-333028
Jhunjhunun
RAJASTHAN
302002
India |
| Phone |
9785377793 |
| Fax |
|
| Email |
dr.ushakumari14@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda, Jaipur, Rajasthan |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
National Institute of Ayurveda,Madhav Vilas Palace, Amer road, Jorawar Singh Gate, Jaipur 302002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Usha Kumari |
PG Department of Prasuti tantra and Stri roga, National Institute of Ayurveda, Jaipur- 302002 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr K Bharathi |
National Institute of Ayurveda, Jaipur |
PG Department of Prasuti tantra and Stri roga, National Institute of Ayurveda, Madhav Vilas Palace, Amer Road, Jowar Singh Gate, Jaipur-302002
Jaipur
RAJASTHAN |
9492047131
baruhunt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe National Institute of Ayurveda, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N91||Absent, scanty and rare menstruation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Lodhra Churana with Krishna Tila Kwatha |
Lodhra Churana (Dose- 3gm BD), Krishna Tila (Dose- 40ml with Prakshepa dravya Guda 10 gm BD)- by Oral route |
| Intervention |
Shatpushpa taila Matra basti |
Shatpushpa, Pippali, Pippalimula, Chavya, Chitraka, Shunthi, Tila taila, Milk, Dose-60ml Just After Food by Anal route
7 alternate days each in 2
consecutive cycles from
the day after the cessation
of menstrual cycle. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
PCOS patients suffering from any of the two features in the following-
Duration of flow less than 2 days.
Reduced quantity of flow (using less than 2 pads/day).
Patients suffering from atleast 2 consecutive cycles with Oligomennorhoea and/ or anovulation.
Patients having hirsutism.
Patient having mid body obesity.
Atleast one ovary showing PCO (diagnosed by USG).
{ESHRE/ASRM- Rotterdam revised criteria for PCOD, 2003} |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women.
Patient with BMI less than 19.
Systemic disorders like- uncontrolled diabetes mellitus, chronic liver disease, renal disorder, high blood pressure, hypo and hyperthyroidism.
Not associated with any organic reproductive system abnormalities (Excluded
clinically and radiologically), pelvic inflammatory disease, hydrosalpinx,
endometriosis, adenomyosis, fibroid uterus, carcinoma of reproductive organ.
Patients having physiological infrequent menstruation.
Woman taking Oral Contraceptive Pills.
Hb. less than 7 gm% |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the detail aetiopathogenesis of Artavakshaya (PCOS) as per classical & modern text.
Changes in the clinical features of Artavakshaya (PCOS).
Attainment of normal menstrual cycle length (21-35days).
To assess the effect of Lodhra Churna with Krishna Tila Kwatha in Artavakshaya.
To assess the effect of Shatapushpa Taila Matra Basti in Artavakshaya. |
2 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement of Quality of Life |
2 months |
|
|
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)
|
10/05/2019 |
| 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="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
Still Under Process |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Polycystic Ovarian Syndrome (PCOS) is a major non-communicable health problem world wide in women of different age groups due to sedentary lifestyle, stress, strain and restlessness. Artavakshaya is seen in the many cases of PCOS. According to Acharya Sushruta in Artavakshaya menstruation is delayed, menstrual blood is scanty and associated with pain in Vagina. PCOS is also a disease of Artavavaha Srotas in which vitiated Vata and Kapha Doshas causing Artavakshaya or Alpartava. The features of PCOS may also be correlated with ‘Pushpaghnee Jataharini’ that is described in Ayurvedic classics (Kashyapa Samhita) having the clinical features of futile ovulation (Vrutha Pushpa) and corpulent hairy cheek (Sthula Lomasha ganda). Lodhra due to its Medokaphahara, Yonidoshahara property and Antiandrogenic effect with Krishna Tila due to its artavajanana property and Shatapushpa due to its rituparvritani, yonishukravishodhani, pittavardhaka properties have been taken in the present study to rule out and compare their therapeutic efficacy in the management of Artavakshaya. |