| CTRI Number |
CTRI/2023/03/051145 [Registered on: 28/03/2023] Trial Registered Prospectively |
| Last Modified On: |
26/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [therapeutic clinical ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of
Kapikacchu churna and Vidari churna in the management of
ksheensukra(low sperm count) |
|
Scientific Title of Study
|
A randomised clinico-comparative trial to evaluate the efficacy of
Kapikacchu churna and Vidari churna in the management of
ksheensukra(Oligozoospermia) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sourava Nayak |
| Designation |
MD scholar |
| Affiliation |
Choudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Room no 153 PG Department of Kayachikitsa Choudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh New Delhi
South West
DELHI
110073
India |
| Phone |
7750942366 |
| Fax |
|
| Email |
nayak.sourav5050@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Varsakiya Jitendra |
| Designation |
Assistant professor |
| Affiliation |
Choudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
PG department of kayachikitsa
Choudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh New Delhi
South West
DELHI
110073
India |
| Phone |
9879158817 |
| Fax |
|
| Email |
jeet12989@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sourava Nayak |
| Designation |
MD scholar |
| Affiliation |
Choudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Room no 153 PG Department of Kayachikitsa Choudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh New Delhi
South West
DELHI
110073
India |
| Phone |
|
| Fax |
|
| Email |
nayak.sourav5050@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ch Brahm Prakash Ayurved Charak Sansthan New Delhi |
|
|
Primary Sponsor
|
| Name |
Ch Brahm Prakash Ayurved Charak Sansthan New Delhi |
| Address |
Choudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Sourava Nayak |
Choudhary Brahm Prakash Ayurved Charak Sansthan |
P.G Department of Kayachikitsa,Choudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh New Delhi
South West
DELHI |
7750942366
nayak.sourav5050@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC CBPACS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N461||Oligospermia. Ayurveda Condition: SUKRAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-करà¥à¤® | (Procedure Reference: Charak Samhita Chikitsa Sthan Chapter 1, Procedure details: Before administration of medicine patients will be done Koshtha Shodhana Karma with Haritakyadi Yoga )
(1) Medicine Name: Haritakyadi Yoga , Reference: Charak Samhita Chikitsa Sthan Chapter 1, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: od, Duration: 1 Days(2) Medicine Name: Vidari Churna, Reference: Bhavprakash Guduchyadi Varga, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Duration: 60 Days | | 2 | Comparator Arm | Procedure | - | virecana-karma, विरेचन-करà¥à¤® | (Procedure Reference: Charak Samhita Chikitsa Sthan Chapter 1, Procedure details: Before administration of the Drug patient will be done Koshtha Shodhana Karma with Haritakyadi Yoga )
(1) Medicine Name: Haritakyadi Yoga, Reference: harak Samhita Chikitsa Sthan Chapter 1, Route: Oral, Dosage Form: Churna/ Powder, Dose: 18(g), Frequency: od, Duration: 1 Days(2) Medicine Name: Kapikachhu Churna, Reference: Bhavprakash Guduchyadi Varga, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Duration: 60 Days |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
Age 21 to 45 years of male
Sperm count less than 15 million per ml according to WHO2010
Subjects who are Yogya for Mridu Virechana
Subjects who are ready to sign the informed consent
Subjects who are not registered in any other research project
Subjects who can take medicine orally |
|
| ExclusionCriteria |
| Details |
Age below 21 and above 45 years.
Sperm count greater then 15 million per ml
Patients of azoospermia and aspermia
Patients of various diseases like varicocele, accessory sex gland infection sexually transmitted
diseases, severe systemic diseases etc
Genetic disorders like Klinfelters syndrome.
Taking treatment for major psychiatric problem
History of previous medications and trauma leading to oligozoospermia
Subjects suffering from Tuberculosis, Diabetes mellitus, Hypertension and Inflammatory bowel
disease
Subjects who are not Yogya for Mridu Virechana.
Subjects who are not ready to sign the informed consent
Subjects who are registered in any other research projerct |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The efficacy of the treatment will be assessed on
the basis of improvement in the sperm count |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Enhancement of fertility rate |
Day 1
Day 16
Day 30
Day 44
Day 60 |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/04/2023 |
| Date of Study Completion (India) |
20/02/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Ksheenshukra is included in one of the varieties of Ashtavidha Shukra Dusti , Where Ksheen means decrease in amount or quality and Shukra is the 7th(terminal) Dhatu.According to acharya sushrut it is vata-pita origin.Lakshanas of Ksheenshukra according to Acharya charaka are weakness, dryness of mouth, pallor, lassitude, exertion, impotency and non- ejaculation of semen. And according to Acharya Sushrutaare pain in the penis and testes, incapacity for copulation, delayed ejaculation and semen being scanty and mixed with blood.Oligozoospermia can be the result of many factors, some are permanent and some are reversible. Causes of Oligozoospermia include an obstruction of the normal flow of sperm due to such conditions as testicular trauma and vasectomy, from infection and sexually transmitted diseases. Other causes are reduced synthesis of testosterone or defective release of FSH and LH from pituitary. As per the principle of Ayurveda, aphrodisiac recipes should be administered after purifying the body . Hence, before administrating in all the registered cases Mridu Shodhana with Haritakyadi Yoga as per classical method will be done. Taking these points into consideration, present study is being planned to evaluate the role of Kapikachhu Churna and Vidari Churna on seminal parameters with special focus on oligozoospermia and possible effect of this trial drug on the hormones FSH, LH and Testosterone levels, which also contribute in spermatogenesis. Total no of patient is 68 ,34 in each group.In group A Kapikachhu churna will be given in dose of 3 gm twice a day half an hour before having a meal with 300 ml of milk.In group B Vidari churna is given in dose of 3 gm twice a day half an hour before having a meal in with 300 ml of milk. Study design is single centerd ,open label,randomised,interventional type,comparative study |